The following data is part of a premarket notification filed by Vesocclude Medical, Llc with the FDA for Vesocclude Ligating Clip.
| Device ID | K091060 |
| 510k Number | K091060 |
| Device Name: | VESOCCLUDE LIGATING CLIP |
| Classification | Clip, Implantable |
| Applicant | VESOCCLUDE MEDICAL, LLC 10419 STALLINGS ROAD Spring Hope, NC 27882 |
| Contact | Diane N Peper |
| Correspondent | Diane N Peper VESOCCLUDE MEDICAL, LLC 10419 STALLINGS ROAD Spring Hope, NC 27882 |
| Product Code | FZP |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-14 |
| Decision Date | 2009-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 60857596005085 | K091060 | 000 |
| 30857596005022 | K091060 | 000 |
| 30857596005046 | K091060 | 000 |
| 30857596005060 | K091060 | 000 |
| 30857596005084 | K091060 | 000 |
| 60857596005009 | K091060 | 000 |
| 60857596005023 | K091060 | 000 |
| 60857596005047 | K091060 | 000 |
| 60857596005061 | K091060 | 000 |
| 30842102105013 | K091060 | 000 |