# K254051: Extroducer Infusion Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: SmartWise Sweden AB
- Decided: Sep 11, 2026 after 268 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: 6 generations back to K913517 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213442: Extroducer Infusion Catheter System, SmartWise Sweden AB (2022) Summary page 5.

## Indications for use
The Extroducer® Infusion Catheter System is intended for infusion of diagnostic or therapeutic solutions into the extravascular area of the peripheral vasculature or intraluminally. The Extroducer® Infusion Catheter System is not intended for use in the coronary or neurovasculature.

Source page: https://510kreport.com/device/K254051
Methodology: https://510kreport.com/methodology