# K163000: AMPLATZER TorqVue 45x45 Delivery Sheath

- Pathway: 510(k) (Special)
- Applicant: Aga Medical COrporation (Wholly Owned by St. Jude Medical CO
- Decided: Dec 23, 2016 after 56 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: 9 generations back to K893658 (1989). 41 ancestors in all.
4 later devices descend from it; 1 cites it directly.
1 of 46 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120120: Amplatzer Torqvue 45X45 Delivery Sheath Amplatzer Torqvue LA1 Delivery Sheath Amplatzer Torqvue LA2 Selivery Sheath, Aga Medical Corporation (2012) Summary page 4.
- K083214: Amplatzer Torqvue  45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100, 9-TV45X45-10F-100, Aga Medical Corp. (2009) Summary page 4.

## Most influential descendants
- K212026: Amplatzer Steerable Delivery Sheath (2021), 3 descendants of its own
- K220340: Amplatzer Steerable Delivery Sheath (2022), 2 descendants of its own
- K232690: Amulet™ Steerable Delivery Sheath (2023), 1 descendant of its own
- K250426: Amulet™ Steerable Delivery Sheath (2025), 0 descendants of its own

## Indications for use
The AMPLATZER™ TorqVue™ 45° x 45° 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/K163000
Methodology: https://510kreport.com/methodology