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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K001135
Device Name 6F & 7F INTRODUCING CATHETERS (MODIFICATION)
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Applicant Contact DENNIS S GRIFFIN
Correspondent
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES,  FL  33014
Correspondent Contact DENNIS S GRIFFIN
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/10/2000
Decision Date 07/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
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