# K212026: Amplatzer Steerable Delivery Sheath

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Medical
- Decided: Sep 27, 2021 after 90 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K893658 (1989). 48 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 52 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163000: AMPLATZER TorqVue 45x45 Delivery Sheath, Aga Medical COrporation (Wholly Owned by St. Jude Medical CO (2016) Summary page 4.
- K081645: Agilis NXT Steerable Introducer, Model G408324, St Jude Medical (2008) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Nov 9, 2021 · Class II · Z-0895-2022: Instructions for use were updated.

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

Source page: https://510kreport.com/device/K212026
Methodology: https://510kreport.com/methodology