# K083214: Amplatzer Torqvue  45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100, 9-TV45X45-10F-100

- Pathway: 510(k) (Special)
- Applicant: Aga Medical Corp.
- Decided: May 12, 2009 after 193 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: 7 generations back to K893658 (1989). 39 ancestors in all.
10 later devices descend from it; 4 cite it directly.
5 of 50 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.

## Most influential descendants
- 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
- K212026: Amplatzer Steerable Delivery Sheath (2021), 3 descendants of its own
- K220340: Amplatzer Steerable Delivery Sheath (2022), 2 descendants of its own
- K180864: WATCHMAN TruSeal Access System (2018), 2 descendants of its own

## Indications for use
The AMPLATZER TorqVue 45°x45° Delivery Sheath is intended to provide a pathway through which devices are introduced within the chambers of the heart.

Source page: https://510kreport.com/device/K083214
Methodology: https://510kreport.com/methodology