510(k) K160454 ยท FZP Clip, Implantable
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
| Applicant | AtriCure, Inc., West Chester OH, US |
| Decision | Substantially Equivalent, Mar 18, 2016 |
| Received | Feb 18, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160454
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 30, 2016 | AtriCure, Inc. AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A single PRO2 device is packaged in a conventional thermoformed polyethylene terephthalate glycol (PETG) tray with a Tyvek lid. Terminated |
FZP | None listed |
| Sep 22, 2016 | AtriCure, Inc. AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
Product is used for the occlusion of the heart's left atrial appendage, under direct visualization, in conjunction with other open c Terminated |
FZP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.