POWERGLIDE MIDLINE CATHETER— 510(k) K121073

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

2012-04-09

Decision date

2012-06-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Salt Lake Ciy,, UT, US

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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 K121073.