K032125 is an FDA 510(k) clearance for the CSTAT, MODELS 09-0014-01 AND 09-0014-02. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Vascular Control Systems, Inc. (San Juan Capistrano, US). The FDA issued a Cleared decision on February 9, 2004, 214 days after receiving the submission on July 10, 2003.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K032125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 2003 |
| Decision Date | February 09, 2004 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | DXC — Clamp, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |