# K213442: Extroducer Infusion Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: SmartWise Sweden AB
- Decided: Jun 10, 2022 after 228 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.
1 later device descends from it; 1 cites it directly.
0 of 10 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.

## Most influential descendants
- K254051: Extroducer Infusion Catheter System (2026), 0 descendants of its own

## Indications for use
The Extroducer Infusion Catheter System is intended for infusion of diagnostic or therapeutic solutions into the perivascular area of the peripheral vasculature. The Extroducer Infusion Catheter System is also intended for the infusion of diagnostic and therapeutic solutions intraluminally.

Source page: https://510kreport.com/device/K213442
Methodology: https://510kreport.com/methodology