Lynx Aspiration Catheter System— 510(k) K254276
Substantially EquivalentQApel Medical, Inc.
FDA 510(k) clearance K254276 for Lynx Aspiration Catheter System, Substantially Equivalent on 2026-05-07. Applicant: QApel Medical, Inc.. Device class: 2.
Summary
QApel Medical's Lynx Aspiration Catheter System is filed under NRY, thrombus retriever catheters.
Class II, 21 CFR 870.1250. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
QApel filed from Fremont, California. Review took 128 calendar days (December 30, 2025 to May 7, 2026).
Clearance details
- Applicant
- QApel Medical, Inc.
- Product code
- Product code NRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fremont, CA, US
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- K263266 — Route 92 Medical Full Length 046 Reperfusion System and Aspiration Tubing Set
- K261089 — Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing Kit
- K260617 — Tigertriever 13 Ultra Revascularization Device
- K262398 — CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing set
More clearances from QApel Medical, Inc.
view allAdverse events under product code NRY
product code NRY- Death
- 411
- Injury
- 1,712
- Malfunction
- 1,855
- Total
- 3,978
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.