# K963446: Kendall Dual Lumen Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
- Decided: Mar 18, 1997 after 196 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 K941851 (1995). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941851: Dual Lumen Catheter (DLC) Tray, Neostar Medical Technologies, Inc. (1995) Summary page 1.

## Most influential descendants
- K063355: D-Line Catheter ST, Double Lumen ST; Extra Flow (2007), 1 descendant of its own
- K102833: Disposable Hemodialysis Access Catheter Sets (2011), 0 descendants of its own

## Indications for use
The Kendall Dual Lumen Catheters are intended for use as short-term vascular access for hemodialysis. The catheters can be inserted in the femoral, subclavian or jugular vein as required.

Source page: https://510kreport.com/device/K963446
Methodology: https://510kreport.com/methodology