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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 K131225
Device Name ADROIT GUIDING CATHETER
Applicant
CORDIS CORP., A JOHNSON & JOHNSON CO.
6500 PASEO PADRE PKWY.
fremont,  CA  94555
Applicant Contact mary e holden
Correspondent
CORDIS CORP., A JOHNSON & JOHNSON CO.
6500 PASEO PADRE PKWY.
fremont,  CA  94555
Correspondent Contact mary e holden
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/30/2013
Decision Date 05/29/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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