K003519 is an FDA 510(k) clearance for the YASARGIL PERMANENT ANEURYSM CLIPS. This device is classified as a Clip, Aneurysm (Class II - Special Controls, product code HCH).
Submitted by Aesculap, Inc. (Allentown, US). The FDA issued a Cleared decision on January 29, 2001, 75 days after receiving the submission on November 15, 2000.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5200.
| 510(k) Number | K003519 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 15, 2000 |
| Decision Date | January 29, 2001 |
| Days to Decision | 75 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 |