K913765 is an FDA 510(k) clearance for the YASARGIL ANEURYSM CLIPS, MODIFICATION. This device is classified as a Clip, Aneurysm (Class II - Special Controls, product code HCH).
Submitted by Aesculap, Inc. (South San Francisco, US). The FDA issued a Cleared decision on March 11, 1992, 202 days after receiving the submission on August 22, 1991.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5200.
| 510(k) Number | K913765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 22, 1991 |
| Decision Date | March 11, 1992 |
| Days to Decision | 202 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | HCH — Clip, Aneurysm |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5200 |