# K203529: VASSALLO GT Hybrid

- Pathway: 510(k) (Traditional)
- Applicant: Filmecc Co., Ltd.
- Decided: May 4, 2021 after 153 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: 14 generations back to K890505 (1989). 43 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150445: ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV), Asahi Intecc Co., Ltd. (2015) Summary page 4.
- K163426: ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension, Asahi Intecc Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K223432: Vassallo GT 018 Hybrid (2023), 0 descendants of its own

## Indications for use
Intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.

Source page: https://510kreport.com/device/K203529
Methodology: https://510kreport.com/methodology