# K261825: Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter

- Pathway: 510(k) (Special)
- Applicant: Abbott
- Decided: Jul 2, 2026 after 30 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: 10 generations back to K893658 (1989). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 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 5.
- K162228: TorqVue Low Profile Delivery Catheter, Aga Medical Corporation (Wholly Owned by St.Jude Medical Cor (2016) Summary page 5.

## Indications for use
The Amplatzer TorqVue LP Delivery System 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. 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/K261825
Methodology: https://510kreport.com/methodology