K200871 is an FDA 510(k) clearance for the Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator. This device is classified as a Aspiration Thrombectomy Catheter (Class II - Special Controls, product code QEZ).
Submitted by Control Medical Technology (Salt Lake City, US). The FDA issued a Cleared decision on May 4, 2020, 33 days after receiving the submission on April 1, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150. To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration..
| 510(k) Number | K200871 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2020 |
| Decision Date | May 04, 2020 |
| Days to Decision | 33 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QEZ - Aspiration Thrombectomy Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |
| Definition | To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration. |