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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 K221832
Device Name SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter
Applicant
Cordis US Corp.
14201 N.W. 60th Avenue
Miami Lakes,  FL  33014
Applicant Contact Luis Davila
Correspondent
Cordis US Corp.
5452 Betsy Ross Drive
Santa Clara,  CA  95054
Correspondent Contact Gina Flores
Regulation Number870.1250
Classification Product Code
LIT  
Date Received06/23/2022
Decision Date 08/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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