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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Diagnostic
510(k) Number K902943
Device Name RSI FEMORAL GUIDING CATHETER
Applicant
Retroperfusion Systems, Inc.
3178 Pullman Ave.
Costa Mesa,  CA  92626
Applicant Contact J. C MACRAE
Correspondent
Retroperfusion Systems, Inc.
3178 Pullman Ave.
Costa Mesa,  CA  92626
Correspondent Contact J. C MACRAE
Regulation Number870.1200
Classification Product Code
DQO  
Date Received07/05/1990
Decision Date 10/03/1990
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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