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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K133843
Device Name SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILATATION CATHETER
Applicant
Cordis Corporation
6500 Paseo Padre Pkwy.
Fremont,  CA  94555
Applicant Contact KIM FONDA
Correspondent
Cordis Corporation
6500 Paseo Padre Pkwy.
Fremont,  CA  94555
Correspondent Contact KIM FONDA
Regulation Number870.1250
Classification Product Code
LIT  
Date Received12/18/2013
Decision Date 06/27/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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