# K210339: Bullfrog Micro-Infusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Mercator Medsystems, Inc.
- Decided: Aug 2, 2021 after 178 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: 5 generations back to K913517 (1991). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161402: Bullfrog Micro-Infusion Device, Mercator Medsystems, Inc. (2016) Summary page 4.

## Indications for use
For Bullfrog devices capable of treating <6 mm diameter vessels: In selective areas of peripheral and coronary vessels, the Bullfrog Micro-Infusion Device is intended for the infusion of diagnostic and therapeutic agents into the vessel wall and perivascular area, or intraluminally. For Bullfrog devices capable only of treating >6 mm diameter vessels: In selective areas of peripheral vessels, the Bullfrog Micro-Infusion Device is intended for infusion of diagnostic and therapeutic agents into the vessel wall and perivascular area, or intraluminally.

Source page: https://510kreport.com/device/K210339
Methodology: https://510kreport.com/methodology