# K231279: Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm

- Pathway: 510(k) (Traditional)
- Applicant: Ablative Solutions, Inc.
- Decided: Jul 5, 2023 after 63 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: 4 generations back to K913517 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140637: Peregrine System Infusion Catheter, Ablative Solutions, Inc. (2014) Summary page 4.

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

Source page: https://510kreport.com/device/K231279
Methodology: https://510kreport.com/methodology