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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 K120492
Device Name K2 MEDICAL VASCULAR CLAMPS
Applicant
K2 Medical GmbH & Co. KG
Unter Buchsteig 3a
Tuttlingen,  DE 78532
Applicant Contact PETER FETZER
Correspondent
K2 Medical GmbH & Co. KG
Unter Buchsteig 3a
Tuttlingen,  DE 78532
Correspondent Contact PETER FETZER
Regulation Number870.4450
Classification Product Code
DXC  
Date Received02/17/2012
Decision Date 04/30/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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