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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K221843
Device Name GEM Biover Microvascular Clamps
Applicant
Synovis Micro Companies Alliance, Inc.
(A Subsidiary Of Baxter International Inc.)
439 Industrial Ln.
Birmingham,  AL  35211
Applicant Contact Julie Carlston
Correspondent
Synovis Micro Companies Alliance, Inc.
(A Subsidiary Of Baxter International Inc.)
439 Industrial Ln.
Birmingham,  AL  35211
Correspondent Contact Julie Carlston
Regulation Number870.4450
Classification Product Code
DXC  
Date Received06/24/2022
Decision Date 09/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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