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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 K190212
Device Name AXS Vecta Aspiration System
Applicant
Stryker Neurovascular
47900 Bayside Parkway
Fremont,  CA  94538
Applicant Contact Shazia Hakim
Correspondent
Stryker Neurovascular
47900 Bayside Parkway
Fremont,  CA  94538
Correspondent Contact Shazia Hakim
Regulation Number870.1250
Classification Product Code
NRY  
Date Received02/04/2019
Decision Date 04/24/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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