# K072313: Amplatzer Torqvue Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Aga Medical Corp.
- Decided: Nov 2, 2007 after 77 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: 6 generations back to K893658 (1989). 38 ancestors in all.
30 later devices descend from it; 11 cite it directly.
5 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033989: Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69, Medtronic Inc. Cardiac Rhythm Management (2004) Summary page 1.

## Most influential descendants
- K083214: Amplatzer Torqvue  45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100, 9-TV45X45-10F-100 (2009), 10 descendants of its own
- K080757: Amplatzer Torqvue Low Profile Delivery System (2008), 7 descendants of its own
- K131063: Amplatzer Torq Vue LP Delivery System (2013), 5 descendants of its own
- K120120: Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1 Delivery Sheath Amplatzer Torqvue LA2 Selivery Sheath (2012), 5 descendants of its own
- K163000: AMPLATZER TorqVue 45x45 Delivery Sheath (2016), 4 descendants of its own

## Recalls of this device
- Dec 18, 2009 · Not classified · Z-1101-2010: In this lot of TorqVue Delivery Systems (PN: 9-ITV10F45/80, LN: 0906151781), the dilator cannot be fully secured to the sheath as directed by the instructions for use.

## Indications for use
The AMPLATZER® TorqVue® 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/K072313
Methodology: https://510kreport.com/methodology