# 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

- Pathway: 510(k) (Traditional)
- Applicant: Gambro Renal Products, Inc.
- Decided: Dec 21, 2010 after 307 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: 2 generations back to K974236 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040301: Gamcath High Flow Catheter, Ref: GDHK 13XX a, Gambro Renal Products (2004) Summary page 3.
- K991320: Medcomp Duo-Flow II Catheter with Lubricious Heparin, Medical Components, Inc. (1999) Summary page 2.

## Indications for use
GamCath® High Flow Dolphin® catheters are indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion and apheresis therapy via the jugular, subclavian or femoral vein. GamCath® High Flow Dolphin® Catheter is not intended for use in pediatric patients.

Source page: https://510kreport.com/device/K100451
Methodology: https://510kreport.com/methodology