K230743 is an FDA 510(k) clearance for the ICHOR 14F Embolectomy System. This device is classified as a Peripheral Mechanical Thrombectomy With Aspiration (Class II - Special Controls, product code QEW).
Submitted by Ichor (Boca Raton, US). The FDA issued a Cleared decision on September 5, 2023, 173 days after receiving the submission on March 16, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150. To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration..
| 510(k) Number | K230743 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 2023 |
| Decision Date | September 05, 2023 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QEW - Peripheral Mechanical Thrombectomy With Aspiration |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |
| Definition | To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Peripheral Vasculature Through Aspiration. |