# K080757: Amplatzer Torqvue Low Profile Delivery System

- Pathway: 510(k) (Special)
- Applicant: Aga Medical Corp.
- Decided: Apr 18, 2008 after 31 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.
7 later devices descend from it; 2 cite it directly.
0 of 47 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
- K131063: Amplatzer Torq Vue LP Delivery System (2013), 5 descendants of its own
- K162228: TorqVue Low Profile Delivery Catheter (2016), 2 descendants of its own
- K241538: TriClip Steerable Guide Catheter (2024), 1 descendant of its own
- K261825: Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter (2026), 0 descendants of its own
- K252417: Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) (2025), 0 descendants of its own

## Indications for use
The AMPLATZER® TorqVue® Low Profile Delivery System is indicated to provide a pathway through which devices are introduced into the peripheral vasculature.

Source page: https://510kreport.com/device/K080757
Methodology: https://510kreport.com/methodology