# K093476: Amplatzer Torq Vue 2 Delivery Sheath Model 9-TV2-05F120, Model 9-TV2-06F120, Modeltv-2-07F120

- Pathway: 510(k) (Traditional)
- Applicant: Aga Medical Corp.
- Decided: Feb 5, 2010 after 88 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). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 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 1.

## Indications for use
The AMPLATZER TorqVue Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.

Source page: https://510kreport.com/device/K093476
Methodology: https://510kreport.com/methodology