K982365 is an FDA 510(k) clearance for the ATRAUMATIC VASCULAR CLAMPS, MODEL #'S 22-XXXX, 23-XXXX, 03-60XX, 25-XXXX MICRO VASCULAR CLAMPS MODEL # 75-0XXX, ATRAUMAT. This device is classified as a Clamp, Vascular (Class II - Special Controls, product code DXC).
Submitted by Geister Medizin Technik GmbH (Tuttlingen, DE). The FDA issued a Cleared decision on April 8, 1999, 275 days after receiving the submission on July 7, 1998.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4450.
| 510(k) Number | K982365 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 1998 |
| Decision Date | April 08, 1999 |
| Days to Decision | 275 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DXC - Clamp, Vascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4450 |