K162771 is an FDA 510(k) clearance for the EkoSonic Endovascular System with Control Unit 4.0. This device is classified as a Mechanical Thrombolysis Catheter (Class II - Special Controls, product code QEY).
Submitted by Btg International, Inc. (Bothell, US). The FDA issued a Cleared decision on February 24, 2017, 144 days after receiving the submission on October 3, 2016.
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 | K162771 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 03, 2016 |
| Decision Date | February 24, 2017 |
| Days to Decision | 144 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. |