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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 K022880
Device Name GUIDANT PROXIMAL SEAL SYSTEM, MODELS PSS-4500 & PS-4500
Applicant
GUIDANT CORP.
3744 MT. DIABLO BLVD.
SUITE 305
LAFAYETTE,  CA  94549
Applicant Contact JEFF SCHAKENRAAD
Correspondent
N.V. KEMA
P.O. BOX 9035
6800 ET ARNHEM
ARNHEM,  NL
Regulation Number870.4450
Classification Product Code
DXC  
Date Received08/30/2002
Decision Date 09/13/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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