K254276
- 510(k) number
- K254276
- Device name
- Lynx Aspiration Catheter System
- Applicant
- QApel Medical, Inc. CA · US
- Product code
- NRY — Catheter, Thrombus Retriever
- Decision date
- 2026-05-07
- Date received
- 2025-12-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K254276.pdf
Official FDA record: K254276
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.