# K213949: VASSALLO GT 018 Floppy

- Pathway: 510(k) (Traditional)
- Applicant: Filmecc Co., Ltd.
- Decided: Jun 30, 2022 after 195 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: 15 generations back to K890505 (1989). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203533: Vassallo GT, Filmecc Co., Ltd. (2021) Summary page 4.

## Indications for use
This product is 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/K213949
Methodology: https://510kreport.com/methodology