K960372 is an FDA 510(k) clearance for the SCANLAN HEIFETZ ANEURYSM ELGILOY CLIP SYSTEM. This device is classified as a Clip, Aneurysm (Class II - Special Controls, product code HCH).
Submitted by Scanlan Intl., Inc. (Saint Paul, US). The FDA issued a Cleared decision on April 26, 1996, 91 days after receiving the submission on January 26, 1996.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5200.
| 510(k) Number | K960372 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 1996 |
| Decision Date | April 26, 1996 |
| Days to Decision | 91 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 |