# K981359: GT Leggiero

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Corp.
- Decided: Jan 27, 1999 after 288 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: 1 generation back to K915414 (1992). 1 ancestor in all.
14 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915414: Terumo Angiogtaphic Catheter, Terumo Medical Corp. (1992) Summary page 1.

## Most influential descendants
- K033583: Progreat (2003), 13 descendants of its own
- K173430: SeQure® NF and SeQure® Microcatheters (2018), 3 descendants of its own
- K033913: Progreat (2004), 3 descendants of its own
- K202797: Drakon and Sequre Microcatheters (2020), 2 descendants of its own
- K203487: Drakon and Sequre Microcatheters (2020), 1 descendant of its own

## Indications for use
The GT Leggiero Catheter is intended for the infusion of contrast media into all peripheral vessels up to and including the cervical vessels, all vessels in the lower and upper extremities and all coronary vessels. The GT Leggiero Catheter is also intended for drug infusion in intra-arterial therapy and the infusion of embolic materials for hemostasis. The Catheter should not be used in cerebral vessels.

Source page: https://510kreport.com/device/K981359
Methodology: https://510kreport.com/methodology