# K965178: Niagara Dual Lumen Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vas-Cath, Inc.
- Decided: Aug 19, 1997 after 238 days
- Product code: MPB (Catheter, Hemodialysis, Non-Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K871488 (1987). 1 ancestor in all.
6 later devices descend from it; 3 cite it directly.
2 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K871488: Vas-Cath Permanent Dual Lumen Hemodialysis Cath, Vas-Cath of Canada, Ltd. (1987) Summary page 2.

## Most influential descendants
- K012193: Amc Antimicrobial Pin/Wire Sleeve (2002), 2 descendants of its own
- K090102: Niagara, Niagara Slim-Cath, and Brevia Short-Term Curved Extension Hemodialysis Catheters (2009), 1 descendant of its own
- K102833: Disposable Hemodialysis Access Catheter Sets (2011), 0 descendants of its own
- K022688: Versabond AB Bone Cement (2004), 0 descendants of its own
- K030268: Niagara Temporary Dual Lumen Catheters; Flexxicon II Temporary Dual Lumen Catheters (2003), 0 descendants of its own

## Indications for use
The Niagara™ Dual Lumen Catheter is indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion or apheresis therapy via the jugular, subclavian or femoral vein.

Source page: https://510kreport.com/device/K965178
Methodology: https://510kreport.com/methodology