# K190884: TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool

- Pathway: 510(k) (Traditional)
- Applicant: Datascope Corp.
- Decided: Dec 26, 2019 after 266 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K842066 (1985). 13 ancestors in all.
No later device cites it as a predicate yet.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111064: Tigerpaw System II, Laax, Inc. (2011) Summary page 4.

## Indications for use
The TigerPaw Pro is indicated for the occlusion of the left atrial appendage, under direct visualization, in conjunction with other open cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).

Source page: https://510kreport.com/device/K190884
Methodology: https://510kreport.com/methodology