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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 K902612
Device Name CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN W/SLX COAT
Applicant
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Applicant Contact TREVISOL-CAPPELLI
Correspondent
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Correspondent Contact TREVISOL-CAPPELLI
Regulation Number870.1330
Classification Product Code
DQX  
Date Received06/13/1990
Decision Date 12/03/1990
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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