# K080994: Amplatzer Torqvue Exchange System

- Pathway: 510(k) (Traditional)
- Applicant: Aga Medical Corp.
- Decided: May 16, 2008 after 39 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.
1 later device descends from it; 1 cites it directly.
0 of 41 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.

## Most influential descendants
- K261631: Amplatzer TorqVue Exchange System (2026), 0 descendants of its own

## Indications for use
The AMPLATZER TorqVue Exchange System is intended for removal of an AMPLATZER Delivery Sheath and subsequent exchange for an AMPLATZER Delivery Sheath of equal or larger diameter.

Source page: https://510kreport.com/device/K080994
Methodology: https://510kreport.com/methodology