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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 K992347
Device Name CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS
Applicant
CORDIS CORP.
40 TECHNOLOGY DR.
WARREN,  NJ  07059
Applicant Contact KAREN WILK
Correspondent
CORDIS CORP.
40 TECHNOLOGY DR.
WARREN,  NJ  07059
Correspondent Contact KAREN WILK
Regulation Number870.1200
Classification Product Code
DQO  
Date Received07/14/1999
Decision Date 10/08/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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