Cruxi
Recorded device evidence
The acquired K230051 file contains product-specific indications and users, design and operating principle, non-clinical evidence actually described sections. Compare these dated manufacturer statements with your own indication and design before commissioning evidence work. They describe this submission; they do not prescribe your testing, validate performance independently or establish a suitable predicate.
Evidence retrieved 2026-10-08. Source versions and topic-specific limits are listed below.
Computed exact-code research
The 2021–2025 complete-year cohort contains 74 selected decisions under primary code DYB. 74 have valid reported receipt/decision pairs; 0 pairs are missing or invalid.
Calendar elapsed days: lower quartile 30.0, median 59.0, upper quartile 127.8. These are recorded calendar differences, not active FDA review time.
The table shows the named decision and up to four latest exact-code research records through 2026-09-27. It can include partial-year records outside the complete-year cohort. The quartiles above use the full stated cohort, not this displayed selection.
| Research record | Recorded device | Receipt → decision | Calendar elapsed days | Recorded submission type |
|---|---|---|---|---|
| K230051 ↗ · this page | 14F iSLEEVE Introducer Set | 2023-01-06 → 2023-02-03 | 28 | Special |
| K253526 ↗ | NAMIC Dilator and Sheath | 2025-11-13 → 2026-07-29 | 258 | Traditional |
| K261529 ↗ | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04) | 2026-05-08 → 2026-07-06 | 59 | Traditional |
| K261242 ↗ | SimplGuide | 2026-04-15 → 2026-06-25 | 71 | Traditional |
| K261950 ↗ | Health Line Tearaway Introducer | 2026-06-10 → 2026-06-22 | 12 | Traditional |
Use this comparison: select a record to investigate, read its actual indications and design, and document differences. A shared code or elapsed period cannot establish its relevance to your device.
Calendar elapsed days are not active FDA review time, a promised schedule or a success probability. The selection includes only the stated recorded decisions, not all applications. Latest records can postdate the named historical decision and are contextual research, not its predicates. Shared codes, summaries and observed records do not prove equivalence, current market availability, buyer applicability or predicate suitability.
Reuse the complete-endpoint exact-primary-code, documented SE-decision cohort and its stated cutoff/window. Retain its type-7 quartiles only when at least 20 valid date pairs are present. Independently subtract the named official record’s receipt date from its decision date; missing or negative pairs remain unknown. Show up to four latest exact-code research records, excluding the named ID. Parent analysis hash, source snapshots and calculation versions are retained.
Calculation: fda-named-decision-cohort-context-1; cutoff 2026-09-27; 0 parent records excluded; units record counts; calendar elapsed days.
Source snapshots: 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002.
Read beyond the decision row
The summary is manufacturer-submitted context hosted by FDA. Negative/no-study statements are preserved. Evidence themes are not binding legal requirements.
Short opening excerpts identify the source sections. Read the linked original for the full study context, negative statements, tables and limitations. Public quotations are limited to 120 words per acquired summary; the internal evidence packet retains exact section ranges for review.
K230051 · PDF page 3 ↗ Source 2
The 14F iSLEEVE Introducer Set is intended to facilitate femoral access to the vascular system for introduction and removal of cardiovascular devices. The iSLEEVE Introducer Set is suitable for use in vessels ≥ 5.5 mm diameter.
Compare with your product: Compare the recorded indication, population, body site and use environment with your proposed label. Record each change instead of assuming the primary code settles intended use.
K230051 · PDF page 4 ↗ Source 3
The 14F iSLEEVE Introducer Set is a sterile, single-use introducer catheter that provides percutaneous access to the femoral artery for introduction and removal of cardiovascular devices into the vascular system.
The excerpt is shortened at a complete statement. Read the complete section in the original PDF before interpreting the evidence.
Compare with your product: Compare physical design, materials, energy, accessories and operating principle with your design. Ask which documented differences change the evidence scope.
K230051 · PDF page 5 ↗ Source 4
Modifications to the predicate device were assessed according to risk-based failure mode effects analysis and with consideration of FDA Guidance, Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, September 8, 2010.
The excerpt is shortened at a complete statement. Read the complete section in the original PDF before interpreting the evidence.
Compare with your product: Treat these as documented evidence themes in this case, including any limitations or negative statements. Ask which protocols, design inputs and acceptance rationale would be justified for your product; these excerpts are not a mandatory test panel.
Select observed whole-line section headings or explicit colon-delimited inline labels on readable PDF pages, including the explicitly documented heading-spacing variants in this parser version. Preserve the original heading, character ranges and layout; do not repair excerpt text. Exclude letter boilerplate and uncertain pages. Stop at observed table headings; do not infer table columns or scalar results from layout text. Multi-column or suspicious split-numeric excerpts are excluded until reviewed alternate extraction is available. Original layout records remain retained; any alternate text has its own extractor-version locator and requires original-page review. For each dimension, prefer usable versioned alternate text where available, selecting its longest usable excerpt; otherwise select the longest usable original-layout excerpt. Ties preserve source order. Bounded to 64 PDF pages and 3,500 characters per section. This is a selection, not a complete dossier analysis.
Excluded extraction items: {}.
Known context: US. Confirm the organisation’s role, relevant activities and markets against the cited criteria.
| Source fact | Recorded value | What to check |
|---|---|---|
| 510(k) identifier | K230051 [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Generic device category | 14F iSLEEVE Introducer Set [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Recorded applicant | Boston Scientific Corporation [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| FDA product code | DYB [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Decision date | 2023-02-03 [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Recorded decision code | SESE [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Submission type | Special [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Receipt date | 2023-01-06 [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Compare the recorded indication, population, body site and use environment with your proposed label. Record each change instead of assuming the primary code settles intended use.
Useful evidence: Our proposed indication, user/population and use environment beside this exact recorded indication.
Compare physical design, materials, energy, accessories and operating principle with your design. Ask which documented differences change the evidence scope.
Useful evidence: Design description, materials/components, accessory list and a differences matrix.
Treat these as documented evidence themes in this case, including any limitations or negative statements. Ask which protocols, design inputs and acceptance rationale would be justified for your product; these excerpts are not a mandatory test panel.
Useful evidence: Existing protocols/results and design-specific evidence gaps, with standard editions and scope reviewed separately.
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002
Sat, 04 Feb 2023 14:01:32 GMT · retrieved 2026-10-08
Source key D02 · snapshot 578605ab4df35245bf22519c2f1e4d810711d0613437bf948619ac4dd27675a3
Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.