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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 K212588
Device Name Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter
Applicant
C.R. Bard, Inc.
1625 W Third St.
Tempe,  AZ  85281
Applicant Contact Arieona Boyle
Correspondent
C.R. Bard, Inc.
1625 W Third St.
Tempe,  AZ  85281
Correspondent Contact Arieona Boyle
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Codes
LIT   OMZ   OZT  
Date Received08/16/2021
Decision Date 05/04/2022
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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