| Device Classification Name |
Clip, Implantable
|
| 510(k) Number |
K260677 |
| Device Name |
Vessel Closure Device (VCD177213P) |
| Applicant |
| Vcd Medical S.R.L. |
| Via Pietro Marone 28 |
|
Brescia,
IT
25124
|
|
| Applicant Contact |
Francesco Piccagli |
| Correspondent |
| RQM+ |
| 5000 Centregreen Way |
| Suite 100 |
|
Cary,
NC
27513
|
|
| Correspondent Contact |
David Worrell |
| Regulation Number | 878.4300 |
| Classification Product Code |
|
| Date Received | 03/02/2026 |
| Decision Date | 09/17/2026 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
Cardiovascular
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|