510(k) K111064 ยท GDW Staple, Implantable
TIGERPAW SYSTEM II
| Applicant | Laax, Inc., Orinda CA, US |
| Decision | Substantially Equivalent, May 18, 2011 |
| Received | Apr 18, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111064
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2015 | Laax, Inc. TIGERPAW System II,
Part number C-TP-1507 (7 connector)
The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA). Terminated |
GDW | None listed |
| Apr 23, 2015 | Laax, Inc. TIGERPAW System II,
Part number C-TP-1509 (9 connector)
The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA). Terminated |
GDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.