K901303 is an FDA 510(k) clearance for the HORIZON SURGICAL LIGATING AND MARKING CLIP. This device is classified as a Clip, Vascular (Class II - Special Controls, product code DSS).
Submitted by Horizon Surgical, Inc. (Evergreen, US). The FDA issued a Cleared decision on June 5, 1990, 77 days after receiving the submission on March 20, 1990.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3250.
| 510(k) Number | K901303 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 1990 |
| Decision Date | June 05, 1990 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
| Product Code | DSS — Clip, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3250 |