# K162228: TorqVue Low Profile Delivery Catheter

- Pathway: 510(k) (Special)
- Applicant: Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor
- Decided: Sep 9, 2016 after 32 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: 9 generations back to K893658 (1989). 41 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131063: Amplatzer Torq Vue LP Delivery System, St Jude Medical (2013) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Mar 17, 2025 · Class II · Z-1644-2025: 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 AMPLATZER™ TorqVue™ LP Catheter is intended 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/K162228
Methodology: https://510kreport.com/methodology