K970050 is an FDA 510(k) clearance for the YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT). 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 November 26, 1997, 324 days after receiving the submission on January 6, 1997.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5200.
| 510(k) Number | K970050 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 1997 |
| Decision Date | November 26, 1997 |
| Days to Decision | 324 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCH — Clip, Aneurysm |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5200 |