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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 K210264
Device Name BD PowerPiCC Catheter
Applicant
Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City,  UT  84116
Applicant Contact Mary Strickland
Correspondent
Bard Access Systems, Inc.
605 North 5600 West
Salt Lake City,  UT  84116
Correspondent Contact Mary Strickland
Regulation Number880.5970
Classification Product Code
LJS  
Date Received02/01/2021
Decision Date 07/30/2021
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
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