POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER— 510(k) K141531

Clearance details

Applicant

C.R. Bard, Inc.

Product code

Code NIE

Device class

Class 2

Regulation

21 CFR 876.5540

Advisory panel

Gastroenterology, Urology

Date received

2014-06-09

Decision date

2015-06-01

Decision

Unknown

Clearance type

Traditional

Location

Salt Lake Ciy,, UT, US

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Death

9

Other

1

Total

10

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-2661-2026 — 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107177 5855300 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107184 5865120 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107191 5865200 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI_DI Code: 00801741107214 5865240 Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter 12 Fr Triple-Lumen UDI-DI Code: 00801741107221 The Power-Trialysis Slim-Cath Short-Term Dialysis Catheter, with a third internal lumen for intravenous therapy, power injection of contrast media, and central venous pressure monitoring, is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, and apheresis treatments. The catheter is intended to be inserted in the jugular, femoral, or subclavian vein as required. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.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 K141531.