# K212738: Amplatzer Talisman Delivery Sheath

- Pathway: 510(k) (Special)
- Applicant: Abbott Medical
- Decided: Sep 27, 2021 after 28 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: 8 generations back to K893658 (1989). 40 ancestors in all.
No later device cites it as a predicate yet.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190581: Amplatzer Trevisio Intravascular Delivery System, Abbott Medical (2019) Summary page 4.

## Indications for use
The Amplatzer Talisman Delivery Sheath is indicated to provide a pathway through which an Amplatzer PFO Occluder is introduced for patent foramen ovale closure

Source page: https://510kreport.com/device/K212738
Methodology: https://510kreport.com/methodology