510(k) K200266

BD Centro Vena Acute Central Line (7 French Dual Lumen) by Bard Access Systems, Inc. (Bard Has Joined Bd) — Product Code FOZ

K200266 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. (Bard Has Joined Bd) for the device "BD Centro Vena Acute Central Line (7 French Dual Lumen)". The FDA issued a decision of Substantially Equivalent on Apr 7, 2020. 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
Apr 7, 2020
Date Received
Feb 3, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

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)