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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K911527
Device Name NOVOSTE GUIDING CATHETER
Applicant
Novoste Corp.
P.O.Box 5149
Montana Industrial Park
Aguadilla,  PR  00605
Applicant Contact LEROY S FORNEY
Correspondent
Novoste Corp.
P.O.Box 5149
Montana Industrial Park
Aguadilla,  PR  00605
Correspondent Contact LEROY S FORNEY
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/04/1991
Decision Date 04/24/1991
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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