# K040139: Endobionics Microsyringe (Usyringe) Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Endobionics, Inc.
- Decided: Feb 18, 2004 after 27 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: 1 generation back to K913517 (1991). 3 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932616: Scimed (R) Dispatch (TM) Coronary Infusion Catheter, Scimed Life Systems, Inc. (1993) Summary page 1.
- K914751: Selective Infusion II Catheter, Advanced Cardiovascular Systems, Inc. (1993) Summary page 1.
- K913517: Isolate Infusion Cathetr System, Lake Region Mfg., Inc. (1991) Summary page 1.

## Most influential descendants
- K062752: Mercator Microsyringe II Infusion Catheter (2006), 8 descendants of its own
- K140637: Peregrine System Infusion Catheter (2014), 6 descendants of its own
- K153501: Bullfrog Micro-Infusion Device (2016), 5 descendants of its own
- K161402: Bullfrog Micro-Infusion Device (2016), 4 descendants of its own
- K213442: Extroducer Infusion Catheter System (2022), 1 descendant of its own

## Indications for use
In selective areas of 2.5 mm diameter peripheral and coronary vessels, the pSyringe Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The pSyringe Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.

Source page: https://510kreport.com/device/K040139
Methodology: https://510kreport.com/methodology