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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 K210324
Device Name V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186
Applicant
Carefusion 2200, Inc.
75 N Fairway Dr.
Vernon Hills,  IL  60061
Applicant Contact Jane Weber
Correspondent
Carefusion 2200, Inc.
75 N Fairway Dr.
Vernon Hills,  IL  60061
Correspondent Contact Jane Weber
Regulation Number870.4450
Classification Product Code
DXC  
Date Received02/04/2021
Decision Date 03/04/2021
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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