The following data is part of a premarket notification filed by Vascular Control Systems, Inc with the FDA for Cstat, Models 09-0014-01 And 09-0014-02.
| Device ID | K032125 |
| 510k Number | K032125 |
| Device Name: | CSTAT, MODELS 09-0014-01 AND 09-0014-02 |
| Classification | Clamp, Vascular |
| Applicant | VASCULAR CONTROL SYSTEMS, INC 32236 PASEO ADELANTO, STE. E San Juan Capistrano, CA 92675 |
| Contact | Kathleen Roberts |
| Correspondent | Kathleen Roberts VASCULAR CONTROL SYSTEMS, INC 32236 PASEO ADELANTO, STE. E San Juan Capistrano, CA 92675 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-10 |
| Decision Date | 2004-02-09 |
| Summary: | summary |