# K173548: Merit Pursue Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Mar 30, 2018 after 134 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K960806 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042568: Excelsior 1018 and SL-10 Microcatheters, Boston Scientific Corp (2004) Summary page 4.

## Recalls of this device
- Nov 6, 2023 · Class II · Z-0628-2024: The sterility of microcatheter and infusion system devices cannot be guaranteed.

## Indications for use
The Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the Microcatheter can be used for the controlled and selective infusion of diagnostics, embolic, or therapeutic materials into vessels. The catheter should not be used in the cerebral vessels.

Source page: https://510kreport.com/device/K173548
Methodology: https://510kreport.com/methodology