The following data is part of a premarket notification filed by Lemaitre Vascular, Inc. with the FDA for Anastoclip Models 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, Anastoclip.
| Device ID | K091987 |
| 510k Number | K091987 |
| Device Name: | ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP |
| Classification | Clip, Implantable |
| Applicant | LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803 |
| Contact | Erin E Daly |
| Correspondent | Erin E Daly LEMAITRE VASCULAR, INC. 63 2ND AVENUE Burlington, MA 01803 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-02 |
| Decision Date | 2010-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840663102471 | K091987 | 000 |
| 00840663102464 | K091987 | 000 |
| 00840663102457 | K091987 | 000 |
| 00840663109593 | K091987 | 000 |
| 00840663109586 | K091987 | 000 |
| 00840663109579 | K091987 | 000 |
| 00840663109562 | K091987 | 000 |