# K222631: Vassallo GT Ext

- Pathway: 510(k) (Traditional)
- Applicant: Filmecc Co., Ltd.
- Decided: Oct 26, 2022 after 56 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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 K890505 (1989). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101985: Asahi Guide Wire Extension 165CM, Asahi Intecc Co., Ltd. (2011) Summary page 4.

## Indications for use
The VASSALLO GT EXT guide wire accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure. This device is intended for peripheral vascular use only.

Source page: https://510kreport.com/device/K222631
Methodology: https://510kreport.com/methodology