# K040301: Gamcath High Flow Catheter, Ref: GDHK 13XX a

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products
- Decided: Nov 1, 2004 after 266 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 K010778 (2001). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010778: Niagara Slim-Cath, C.R. Bard, Inc. (2001) Summary page 1.

## Most influential descendants
- K100451: Gamcath High Flow Dolphin MS-GDHC-1315 a; and MS-GDHC-1315J a, Gamcath High Flow Dolphin MS-GDHC-1320 a; and MS-GDHC-132 (2010), 0 descendants of its own

## Indications for use
GamCath® catheters are indicated for use in attaining short-term vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein. Not for pediatric use.

Source page: https://510kreport.com/device/K040301
Methodology: https://510kreport.com/methodology