NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS— 510(k) K030268

Clearance details

Applicant

C.R. Bard, Inc.

Product code

Code MPB

Device class

Class 2

Regulation

21 CFR 876.5540

Advisory panel

Gastroenterology, Urology

Date received

2003-01-27

Decision date

2003-07-30

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Salt Lake City, UT, US

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• K163458 — Zenysis Short-Term Dialysis Catheter2017-04-04

• 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

18

Malfunction

1,042

Total

1,060

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-2657-2026 — 5625240 DuoGlide Short-Term Straight Dialysis Catheter 13 Fr Dual-Lumen UDI-DI Code: 00801741042119 The intended use of the Short-Term Dialysis Catheter is attaining temporary/short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian, or femoral vein.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 K030268.