# K091793: Amplatzer Torqvue 3 Delivery Sheath, Model 9-TV3-08F104, 9-TV3-08F54

- Pathway: 510(k) (Special)
- Applicant: Aga Medical Corp.
- Decided: Jul 9, 2009 after 22 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: 8 generations back to K893658 (1989). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 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 1.

## Indications for use
The AMPLATZER ® TorqVue® 3 Delivery Sheath is intended to provide a pathway through which devices are introduced within the peripheral vasculature.

Source page: https://510kreport.com/device/K091793
Methodology: https://510kreport.com/methodology