K211080 is an FDA 510(k) clearance for the EkoSonic Endovascular Device. This device is classified as a Mechanical Thrombolysis Catheter (Class II - Special Controls, product code QEY).
Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on November 19, 2021, 221 days after receiving the submission on April 12, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150. To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature..
| 510(k) Number | K211080 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 12, 2021 |
| Decision Date | November 19, 2021 |
| Days to Decision | 221 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QEY — Mechanical Thrombolysis Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |
| Definition | To Mechanically Disrupt Thrombus And/or Debris In The Peripheral Vasculature. |