POWERGLIDE MIDLINE CATHETER— 510(k) K133856

Clearance details

Applicant

C.R. Bard, Inc.

Product code

Code FOZ

Device class

Class 2

Regulation

21 CFR 880.5200

Advisory panel

General Hospital

Date received

2013-12-19

Decision date

2014-01-16

Decision

Substantially Equivalent

Clearance type

Special

Location

Salt Lake Ciy,, UT, US

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• K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more2026-07-10
• K254076 — BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit2026-05-29
• K252971 — Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)2026-03-17
• K251864 — Rubber Utility Catheter2026-02-23
• K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)2025-05-15

Death

38

Injury

2,290

Malfunction

25,858

Other

11

Total

28,197

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1274-2015 — BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlide Midline Catheter Full Kit (20G) (10cm), The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.Class II·Terminated·Bard Access Systems·20140808

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133856.