K192068 is an FDA 510(k) clearance for the i-ED COIL. This device is classified as a Device, Neurovascular Embolization (Class II - Special Controls, product code HCG).
Submitted by Kaneka Pharma America, LLC (New York, US). The FDA issued a Cleared decision on April 25, 2020, 268 days after receiving the submission on August 1, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5950.
| 510(k) Number | K192068 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 01, 2019 |
| Decision Date | April 25, 2020 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCG - Device, Neurovascular Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5950 |