K202821 is an FDA 510(k) clearance for the Indigo Aspiration System - Aspiration Catheter 12 and Separator 12. This device is classified as a Peripheral Mechanical Thrombectomy With Aspiration (Class II - Special Controls, product code QEW).
Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on November 18, 2020, 55 days after receiving the submission on September 24, 2020.
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 | K202821 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2020 |
| Decision Date | November 18, 2020 |
| Days to Decision | 55 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. |