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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K021593
Device Name MODIFICATION TO ENVOY AND VISTA BRITE TIP
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
miami lakes,  FL  33014
Applicant Contact stephen m enos
Correspondent
CORDIS CORP.
14201 N.W. 60TH AVE.
miami lakes,  FL  33014
Correspondent Contact stephen m enos
Regulation Number870.1250
Classification Product Code
DQY  
Date Received05/15/2002
Decision Date 06/13/2002
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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