# K250426: Amulet™ Steerable Delivery Sheath

- Pathway: 510(k) (Special)
- Applicant: Abbott Medical
- Decided: Apr 25, 2025 after 70 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: 13 generations back to K893658 (1989). 51 ancestors in all.
No later device cites it as a predicate yet.
1 of 52 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232690: Amulet™ Steerable Delivery Sheath, Abbott Medical (2023) Summary page 5.

## Indications for use
The Amulet™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer™ Amulet™ Left Atrial Appendage Occluder.

Source page: https://510kreport.com/device/K250426
Methodology: https://510kreport.com/methodology