# K171176: M-CATH Microcatheter

- Pathway: 510(k) (Traditional)
- Applicant: Acrostak (Schweiz) AG
- Decided: Sep 15, 2017 after 147 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: 7 generations back to K001992 (2000). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082519: Finecross MG Coronary Micro-Guide Catheter, Terumo Medical Corp. (2008) Summary page 4.
- K083127: Asahi Corsair Microcatheter, Asahi Intecc Co., Ltd. (2009) Summary page 4.

## Indications for use
The M-CATH Microcatheter is intended to provide support to the guide wire while performing PCI (percutaneous coronary intervention) and to facilitate the exchange of guide wires while maintaining access to distal vasculature. The device is also intended to deliver radiopaque contrast media into the coronary vasculature.

Source page: https://510kreport.com/device/K171176
Methodology: https://510kreport.com/methodology