# K991619: FOUNTAIN Infusion Catheter and Occluding Guide Wire

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jun 9, 1999 after 29 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- 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 K904788 (1990). 3 ancestors in all.
43 later devices descend from it; 4 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974067: Fountain Infusion  Catheter  and Occluding Guide Wire, Merit Medical Systems, Inc. (1998) Summary page 5.

## Most influential descendants
- K992231: FOUNTAIN Infusion Catheter and Occluding Guide Wire (1999), 40 descendants of its own
- K041629: Lysus Infusion System (2004), 39 descendants of its own
- K042456: Lysus Infusion System (2004), 38 descendants of its own
- K051319: Lysus Infusion System (2005), 35 descendants of its own
- K052071: Lysus Infusion System (2005), 34 descendants of its own

## Indications for use
The FOUNTAIN™ Infusion Catheter and Occluding Guide Wire is intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient

Source page: https://510kreport.com/device/K991619
Methodology: https://510kreport.com/methodology