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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K032050
Device Name PERIVAC KIT
Applicant
BOSTON SCIENTIFIC CORP.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Applicant Contact RONALD C ALLEN
Correspondent
BOSTON SCIENTIFIC CORP.
2710 ORCHARD PKWY.
SAN JOSE,  CA  95134
Correspondent Contact RONALD C ALLEN
Regulation Number870.1330
Classification Product Code
DQX  
Date Received07/02/2003
Decision Date 08/08/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Recalls CDRH Recalls
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