# K140637: Peregrine System Infusion Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ablative Solutions, Inc.
- Decided: Mar 26, 2014 after 14 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.
6 later devices descend from it; 2 cite it directly.
0 of 12 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 1.
- (no number) Rex Medical Quadra-Fuse Multi-pronged Injection Needle: named in the summary without a submission number

## 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
- K231279: Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm (2023), 0 descendants of its own
- K222185: Stratus Infusion Catheter (2023), 0 descendants of its own

## Indications for use
The Peregrine System is intended for the infusion of diagnostic and therapeutic agents into the perivascular area.

Source page: https://510kreport.com/device/K140637
Methodology: https://510kreport.com/methodology