# K131063: Amplatzer Torq Vue LP Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Aug 15, 2013 after 121 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K893658 (1989). 40 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 46 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.
- K080757: Amplatzer Torqvue Low Profile Delivery System, Aga Medical Corp. (2008) Summary page 2.

## Most influential descendants
- 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
- K243224: MitraClip™ G5 Steerable Guide Catheter (SGC0801); TriClip™ G5 Steerable Guide Catheter (TSGC0801) (2024), 0 descendants of its own

## Recalls of this device
- Mar 17, 2025 · Class II · Z-1643-2025: Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air

## Indications for use
The AMPLAYZER* TorqVueo Low Profile Delivery System 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/K131063
Methodology: https://510kreport.com/methodology