# K190581: Amplatzer Trevisio Intravascular Delivery System

- Pathway: 510(k) (Special)
- Applicant: Abbott Medical
- Decided: Apr 5, 2019 after 30 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.
2 later devices descend from it; 2 cite it directly.
0 of 42 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 4.

## Most influential descendants
- K260499: Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 (2026), 0 descendants of its own
- K212738: Amplatzer Talisman Delivery Sheath (2021), 0 descendants of its own

## Indications for use
The Amplatzer™ Trevisio™ Intravascular Delivery System is intended 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/K190581
Methodology: https://510kreport.com/methodology