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FDA 510(k)

Lynx Aspiration Catheter System

K-Number: K254276 · 2026-05-07

Decision Date2026-05-07
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Lynx Aspiration Catheter System is a medical device manufactured by Q’Apel Medical, Inc.. It received FDA 510(k) clearance on 2026-05-07 under approval number K254276. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lynx Aspiration Catheter System?

Lynx Aspiration Catheter System is a medical device that received FDA 510(k) clearance on 2026-05-07. It is manufactured by Q’Apel Medical, Inc.. The 510(k) number is K254276.

When was Lynx Aspiration Catheter System approved by the FDA?

Lynx Aspiration Catheter System received FDA 510(k) clearance on 2026-05-07, under approval number K254276.

What company makes Lynx Aspiration Catheter System?

Lynx Aspiration Catheter System is manufactured by Q’Apel Medical, Inc..

What is the FDA product code for Lynx Aspiration Catheter System?

The FDA product code for Lynx Aspiration Catheter System is NRY.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.