# K232536: Soldier Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Embolx, Inc.
- Decided: Feb 23, 2024 after 186 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- 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 K915414 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033583: Progreat, Terumo Medical Corp. (2003) Summary page 5.
- K170223: Progreat, Ashitaka Factory of Terumo Corporation (2017) Summary page 5.

## Indications for use
The Soldier Microcatheter is indicated for use in the blood vessels of the peripheral vasculature. It is intended to assist in the delivery of diagnostic agents and therapeutic agents into the target treatment area. The Soldier Microcatheter is intended for Prescription Use Only.

Source page: https://510kreport.com/device/K232536
Methodology: https://510kreport.com/methodology