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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 K183464
Device Name AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)
Applicant
Stryker
47900 Bayside Pkwy.
Fremont,  CA  94538
Applicant Contact Germaine Fu
Correspondent
Stryker
47900 Bayside Pkwy.
Fremont,  CA  94538
Correspondent Contact Germaine Fu
Regulation Number870.1250
Classification Product Code
NRY  
Date Received12/14/2018
Decision Date 03/13/2019
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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