K870399 is an FDA 510(k) clearance for the SELVERSTONE CLAMP SALIBI CLAMP. This device is classified as a Clamp, Carotid Artery (Class II - Special Controls, product code HCE).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on March 6, 1987, 32 days after receiving the submission on February 2, 1987.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5175.
| 510(k) Number | K870399 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1987 |
| Decision Date | March 06, 1987 |
| Days to Decision | 32 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | - |
| Product Code | HCE - Clamp, Carotid Artery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5175 |