# K111064: Tigerpaw System II

- Pathway: 510(k) (Special)
- Applicant: Laax, Inc.
- Decided: May 18, 2011 after 30 days
- Product code: GDW (Staple, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4750
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K842066 (1985). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 14 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101961: Tigerpaw System, Laax, Inc. (2010) Summary page 1.

## Most influential descendants
- K190884: TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool (2019), 0 descendants of its own

## Recalls of this device
- Mar 25, 2015 · Class I · Z-1461-2015: Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by
- Mar 25, 2015 · Class I · Z-1462-2015: Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by

## Indications for use
The TigerPaw® System H 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, 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/K111064
Methodology: https://510kreport.com/methodology