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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, Short-Term Less Than 30 Days
510(k) Number K190855
Device Name BD Acute Central Line
Applicant
Bard Access Systems, Inc. (Bard Has Joined Bd)
605 N. 5600 W.
Salt Lake Ciy,,  UT  84116
Applicant Contact Sean J. Loring
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received04/02/2019
Decision Date 11/01/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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