K031468 is an FDA 510(k) clearance for the TEMPORARY TITANIUM ANEURYSM CLIP. This device is classified as a Clip, Aneurysm (Class II - Special Controls, product code HCH).
Submitted by Cardinalhealth (Mcgaw Park, US). The FDA issued a Cleared decision on June 20, 2003, 42 days after receiving the submission on May 9, 2003.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5200.
| 510(k) Number | K031468 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2003 |
| Decision Date | June 20, 2003 |
| Days to Decision | 42 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 |