510(k) K190855

BD Acute Central Line by Bard Access Systems, Inc. (Bard Has Joined Bd) — Product Code FOZ

K190855 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. (Bard Has Joined Bd) for the device "BD Acute Central Line". The FDA issued a decision of Substantially Equivalent on Nov 1, 2019. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Bard Access Systems, Inc. (Bard Has Joined Bd) has 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 1, 2019
Date Received
Apr 2, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type
510(k)