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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K201452
Device Name Groshong NXT PICC Catheter
Applicant
C.R. Bard, Inc.
605 North 5600 West
Salt Lake City,  UT  84116
Applicant Contact Matthew Lyman
Correspondent
C.R. Bard, Inc.
605 North 5600 West
Salt Lake City,  UT  84116
Correspondent Contact Matthew Lyman
Regulation Number880.5970
Classification Product Code
LJS  
Date Received06/01/2020
Decision Date 03/12/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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