# K030268: Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen Catheters

- Pathway: 510(k) (Abbreviated)
- Applicant: C.R. Bard, Inc.
- Decided: Jul 30, 2003 after 184 days
- Product code: MPB (Catheter, Hemodialysis, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K871488 (1987). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K965178: Niagara Dual Lumen Catheter, Vas-Cath, Inc. (1997) Summary page 1.
- K914162: Vas-Cath Flexxicon 2 Dual Lumen Dialysis Catheters, Vas-Cath, Inc. (1993) Summary page 1.

## Recalls of this device
- Aug 10, 2026 · Class I · Z-2985-2026: this is a downstream recall of class I recall RES 98777
- May 21, 2026 · Class II · Z-2657-2026: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

## Indications for use
Niagara Dual Lumen Catheters are indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular, subclavian or femoral vein.

Source page: https://510kreport.com/device/K030268
Methodology: https://510kreport.com/methodology