# K090102: Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension Hemodialysis Catheters

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Feb 12, 2009 after 28 days
- Product code: MPB (Catheter, Hemodialysis, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 1 (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). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 6 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.
- K010778: Niagara Slim-Cath, C.R. Bard, Inc. (2001) Summary page 1.
- K881743: Vas-Cath Flexxicon Dual Lumen Dialysis Catheter, Vas-Cath, Inc. (1988) Summary page 2.

## Most influential descendants
- K102833: Disposable Hemodialysis Access Catheter Sets (2011), 0 descendants of its own

## Recalls of this device
- Aug 10, 2026 · Class I · Z-2985-2026: this is a downstream recall of class I recall RES 98777

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

Source page: https://510kreport.com/device/K090102
Methodology: https://510kreport.com/methodology