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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 K934474
Device Name PILOT CARDIOVASCULAR SYSTEMS 2 CM PILOT WIRE
Applicant
Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard
1062-F Calloe Negocio
San Clemente,  CA  92673
Applicant Contact LINDA D'ABATE
Correspondent
Pilot Cardiovascular Systems, Inc., Sub. C.R. Bard
1062-F Calloe Negocio
San Clemente,  CA  92673
Correspondent Contact LINDA D'ABATE
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/14/1993
Decision Date 11/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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