K091987 is an FDA 510(k) clearance for the ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP. This device is classified as a Clip, Implantable (Class II - Special Controls, product code FZP).
Submitted by LeMaitre Vascular, Inc. (Bedford, US). The FDA issued a Cleared decision on April 23, 2010, 295 days after receiving the submission on July 2, 2009.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4300.
| 510(k) Number | K091987 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2009 |
| Decision Date | April 23, 2010 |
| Days to Decision | 295 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | FZP — Clip, Implantable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4300 |