# K121611: Amplatzer Torqvue FX

- Pathway: 510(k) (Traditional)
- Applicant: Aga Medical Corporation
- Decided: Aug 23, 2012 after 83 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (1 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.
No later device cites it as a predicate yet.
1 of 41 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072313: Amplatzer Torqvue Delivery System, Aga Medical Corp. (2007) Summary page 2.
- K083214: Amplatzer Torqvue  45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100, 9-TV45X45-10F-100, Aga Medical Corp. (2009) Summary page 2.

## Recalls of this device
- Jan 18, 2013 · Class I · Z-0763-2013: The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and usage conditions.

## Indications for use
The AMPLATZER® TorqVue FX Delivery System is intended to provide a pathway through which devices are introduced within the chambers of the heart.

Source page: https://510kreport.com/device/K121611
Methodology: https://510kreport.com/methodology