# K193082: Fountain ValveTip Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Aug 7, 2020 after 276 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- 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.
No later device cites it as a predicate yet.
0 of 4 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 4.

## Indications for use
The Fountain ValveTip Infusion System is intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

Source page: https://510kreport.com/device/K193082
Methodology: https://510kreport.com/methodology