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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 K143412
Device Name ADROIT Guiding Catheter
Applicant
CORDIS CORPORATION
6500 PASEO PADRE PKWY
FREMONT,  CA  94555
Applicant Contact BABU PERIASAMY
Correspondent
CORDIS CORPORATION
6500 PASEO PADRE PKWY
FREMONT,  CA  94555
Correspondent Contact BABU PERIASAMY
Regulation Number870.1250
Classification Product Code
DQY  
Date Received11/28/2014
Decision Date 01/14/2015
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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