# K153501: Bullfrog Micro-Infusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Mercator Medsystems, Inc.
- Decided: Apr 15, 2016 after 130 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: 3 generations back to K913517 (1991). 5 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062752: Mercator Microsyringe II Infusion Catheter, Mercator Medsystems, Inc. (2006) Summary page 4.

## Most influential descendants
- K161402: Bullfrog Micro-Infusion Device (2016), 4 descendants of its own
- K213442: Extroducer Infusion Catheter System (2022), 1 descendant of its own
- K254051: Extroducer Infusion Catheter System (2026), 0 descendants of its own
- K222185: Stratus Infusion Catheter (2023), 0 descendants of its own
- K210339: Bullfrog Micro-Infusion Device (2021), 0 descendants of its own

## Indications for use
In selective areas of peripheral and coronary vessels, the Bullfrog Micro-Infusion Device is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The Bullfrog Micro-Infusion Device is also intended for the infusion of diagnostic and therapeutic agents intraluminally.

Source page: https://510kreport.com/device/K153501
Methodology: https://510kreport.com/methodology