# K203533: Vassallo GT

- Pathway: 510(k) (Traditional)
- Applicant: Filmecc Co., Ltd.
- Decided: Apr 21, 2021 after 140 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.
3 later devices descend from it; 3 cite it directly.
0 of 47 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
- K232574: VASSALLO GT Crossing14 (2023), 0 descendants of its own
- K232578: Vassallo GT 018 G12; Vassallo GT 018 G30 (2023), 0 descendants of its own
- K213949: VASSALLO GT 018 Floppy (2022), 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/K203533
Methodology: https://510kreport.com/methodology