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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 K192318
Device Name Ultraverse 014 and 018 PTA Balloon Dilatation Catheters
Applicant
Bard Peripheral Vascular, Inc.
1625 West 3rd St
Tempe,  AZ  85281
Applicant Contact Andrew Quach
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.1250
Classification Product Code
LIT  
Date Received08/26/2019
Decision Date 10/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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