# K100184: Fustar Steerable Introducers

- Pathway: 510(k) (Traditional)
- Applicant: Lifetech Scientific (Shenzhen) Co., Ltd.
- Decided: Feb 14, 2011 after 389 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: 7 generations back to K893658 (1989). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072313: Amplatzer Torqvue Delivery System, Aga Medical Corp. (2007) Summary page 2.
- K061119: Enpath Medical Steerable Sheath, Enpath Medical, Inc. (2006) Summary page 2.

## Indications for use
FuStarM Steerable Introducer is indicated to provide a pathway through which devices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature.

Source page: https://510kreport.com/device/K100184
Methodology: https://510kreport.com/methodology