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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 K875127
Device Name NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS
Applicant
Novoste Corp.
17345 NW 62nd Pl. S.
Miami,  FL  33015
Applicant Contact THOMAS D WELDON
Correspondent
Novoste Corp.
17345 NW 62nd Pl. S.
Miami,  FL  33015
Correspondent Contact THOMAS D WELDON
Regulation Number870.1200
Classification Product Code
DQO  
Date Received12/15/1987
Decision Date 08/09/1988
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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