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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K904287
Device Name STEALTH DILATION CATHETER SYSTEM/MODIFICATION
Applicant
Target Therapeutics
130 Rio Robles
P.O. Box 610458
San Jose,  CA  95134
Applicant Contact MARIE DANIELS
Correspondent
Target Therapeutics
130 Rio Robles
P.O. Box 610458
San Jose,  CA  95134
Correspondent Contact MARIE DANIELS
Regulation Number870.1240
Classification Product Code
DYG  
Date Received09/14/1990
Decision Date 01/16/1991
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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