# K203521: FineCross M3

- Pathway: 510(k) (Traditional)
- Applicant: Ashitaka Factory of Terumo Corporation
- Decided: Mar 3, 2021 after 92 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: 6 generations back to K001992 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 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 5.

## Indications for use
The product (FineCross M3) is intended to be percutaneously introduced into blood vessels and support a guide wire while performing PCI (percutaneous coronary intervention). The product is also intended for injection of radiopaque contrast media for angiography. The product should not be used in cerebral and peripheral vessels.

Source page: https://510kreport.com/device/K203521
Methodology: https://510kreport.com/methodology