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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K221440
Device Name Liverty™ TIPS Access Set
Applicant
Bard Peripheral Vascular, Inc
1625 West 3rd Street
Tempe,  AZ  85281
Applicant Contact Scott Johnson
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/17/2022
Decision Date 05/31/2022
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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