3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers +1 more— 510(k) K180548

Clearance details

Device name as filed

3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology

Applicant

C.R. Bard, Inc (Bard Has Joined Bd)

Product code

Code LJS

Device class

Class 2

Regulation

21 CFR 880.5970

Advisory panel

General Hospital

Date received

2018-03-01

Decision date

2018-04-26

Decision

Substantially Equivalent

Clearance type

Special

Location

Salt Lake Ciy,, UT, US

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• K252792 — PM2 System with ECGuide Connector2025-11-17
• K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301) +5 more2025-08-01
• K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)2025-07-01

Death

31

Injury

2,791

Malfunction

18,374

Other

5

Total

21,201

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-2664-2026 — CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188800 CK000884A PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741219177 CK001000 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741223020 CK001066 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228544 CK001068 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741228728 S1173108D PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741130342 S1173108D1 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154720 S1173108D4 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155031 S1173108D5 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155130 S1173108D6 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741232190 S1193108D3 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741154980 S1193108D4 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155086 S1193108D5 PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741155185 S1193108PD PowerPICC Provena SOLO Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741134135 S1274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130366 S1274108D4 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155055 S1274108D5 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155154 S1294108D PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130373 S1294108D2 PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741154898 S1294108D4 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155109 S1294108D5 PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741155208 S3173108 PowerPICC Provena Catheter 3 Fr Single-Lumen UDI-DI Code: 00801741130144 S3274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130403 S9274108D PowerPICC Provena Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741130441 The PowerPICC Provena Catheters and PowerPICC Provena Catheter with SOLO Valve Technology are indicated for short and long term peripheral access to central venous system for intravenous therapy, blood sampling, power injection of contrast media, and allow for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 guage or larger be used.Class II·Ongoing·Bard Access Systems, Inc.·20260521

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180548.