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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 K922891
Device Name CORDIS 7 FRENCH THRULUMEN CATHETER
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact TYE MINNICK
Correspondent
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact TYE MINNICK
Regulation Number870.1200
Classification Product Code
DQO  
Date Received06/16/1992
Decision Date 06/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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