K093679 is an FDA 510(k) clearance for the ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by AtriCure, Inc. (West Chester, US). The FDA issued a Cleared decision on June 10, 2010, 195 days after receiving the submission on November 27, 2009.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K093679 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2009 |
| Decision Date | June 10, 2010 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FZP — Clip, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |