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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Thrombus Retriever
510(k) Number K254276
Device Name Lynx Aspiration Catheter System
Applicant
Q’Apel Medical, Inc.
4245 Technology Dr.
Fremont,  CA  94538
Applicant Contact Jennifer Mateus
Correspondent
Q’Apel Medical, Inc.
4245 Technology Dr.
Fremont,  CA  94538
Correspondent Contact Jennifer Mateus
Regulation Number870.1250
Classification Product Code
NRY  
Date Received12/30/2025
Decision Date 05/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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