The following data is part of a premarket notification filed by Vascular Control Systems, Inc with the FDA for Transvaginal Doppler Clamp, Models: 09-0016-01, 09-0016-02, 09-0016-03.
| Device ID | K031812 |
| 510k Number | K031812 |
| Device Name: | TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03 |
| Classification | Clamp, Vascular |
| Applicant | VASCULAR CONTROL SYSTEMS, INC 32236- E PASEO ADELANTO San Juan Capistrano, CA 92675 |
| Contact | Al Memmolo |
| Correspondent | Al Memmolo VASCULAR CONTROL SYSTEMS, INC 32236- E PASEO ADELANTO San Juan Capistrano, CA 92675 |
| Product Code | DXC |
| Subsequent Product Code | HHM |
| Subsequent Product Code | ITX |
| Subsequent Product Code | JAF |
| Subsequent Product Code | MDC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-12 |
| Decision Date | 2003-12-12 |
| Summary: | summary |