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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 K110193
Device Name FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH; FEMOSTOP II PLUS SET; FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER; F
Applicant
St. Jude Medical Systems AB
Palmbladsgatan 10
Uppsala,  SE SE-751 35
Applicant Contact KATRIN SVENSSON
Correspondent
St. Jude Medical Systems AB
Palmbladsgatan 10
Uppsala,  SE SE-751 35
Correspondent Contact KATRIN SVENSSON
Regulation Number870.4450
Classification Product Code
DXC  
Date Received01/24/2011
Decision Date 02/24/2011
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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