# K992231: FOUNTAIN Infusion Catheter and Occluding Guide Wire

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jul 23, 1999 after 21 days
- Product code: QEY (Mechanical Thrombolysis Catheter)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K904788 (1990). 4 ancestors in all.
40 later devices descend from it; 1 cites it directly.
0 of 45 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.
- K991619: FOUNTAIN Infusion Catheter and Occluding Guide Wire, Merit Medical Systems, Inc. (1999) Summary page 5.

## Most influential descendants
- 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
- K060422: Lysus Infusion System (2006), 27 descendants of its own

## Recalls of this device
- Nov 6, 2023 · Class II · Z-0629-2024: The sterility of microcatheter and infusion system devices cannot be guaranteed.
- May 14, 2008 · Not classified · Z-2107-2008: Catheters were packaged with occluding wires that were too long for the catheter. Potential for wire to not occlude the catheter appropriately, allowing the wire to exit the tip of the catheter furthe

## 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/K992231
Methodology: https://510kreport.com/methodology