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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter For Crossing Total Occlusions
510(k) Number K150836
Device Name OUTBACK Elite Re-Entry Catheter
Applicant
Cordis Corporation, A Johnson & Johnson Co.
6500 Paseo Padre Pkwy.
Fremont,  CA  94555
Applicant Contact MICHELLE RAGOZZINO RODGERS
Correspondent
Cordis Corporation, A Johnson & Johnson Co.
6500 Paseo Padre Pkwy.
Fremont,  CA  94555
Correspondent Contact MICHELLE RAGOZZINO RODGERS
Regulation Number870.1250
Classification Product Code
PDU  
Date Received03/30/2015
Decision Date 04/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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