510(k) K240359

PowerGlide Pro™ Midline Catheter by Becton, Dickinson And Company (Bard Access Systems, Inc.) — Product Code FOZ

K240359 is an FDA 510(k) premarket notification submitted by Becton, Dickinson And Company (Bard Access Systems, Inc.) for the device "PowerGlide Pro™ Midline Catheter". The FDA issued a decision of Substantially Equivalent on Jul 29, 2024. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 29, 2024
Date Received
Feb 6, 2024
Clearance Type
Traditional
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