# K232647: Microcatheter

- Pathway: 510(k) (Special)
- Applicant: Surmodics,Inc.
- Decided: Sep 29, 2023 after 29 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K001992 (2000). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173560: Microcatheter, Surmodics,Inc. (2018) Summary page 5.

## Indications for use
The Surmodics Microcatheter is intended to provide support to facilitate the placement of guidewires in the coronary and peripheral vasculatures and can be used to exchange one guidewire for another. This microcatheter is also intended to assist in the delivery of contrast media into the coronary and peripheral vasculatures. Do not use this microcatheter other than for use in the coronary and peripheral vasculatures.

Source page: https://510kreport.com/device/K232647
Methodology: https://510kreport.com/methodology