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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 K203275
Device Name Recon Support Catheter
Applicant
C.R. Bard, 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
DQY  
Date Received11/06/2020
Decision Date 03/01/2021
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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