K200083 is an FDA 510(k) clearance for the EMBA Hourglass Peripheral Embolization Device (PED). This device is classified as a Device, Vascular, For Promoting Embolization (Class II - Special Controls, product code KRD).
Submitted by Embolic Acceleration, LLC (Miami, US). The FDA issued a Cleared decision on February 14, 2020, 30 days after receiving the submission on January 15, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3300.
| 510(k) Number | K200083 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 15, 2020 |
| Decision Date | February 14, 2020 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRD - Device, Vascular, For Promoting Embolization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3300 |