K163618 is an FDA 510(k) clearance for the INDIGO Aspiration System. This device is classified as a Coronary Mechanical Thrombectomy With Aspiration (Class II - Special Controls, product code QEX).
Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on May 24, 2017, 153 days after receiving the submission on December 22, 2016.
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 Coronary Vasculature Through Aspiration..
| 510(k) Number | K163618 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | December 22, 2016 |
| Decision Date | May 24, 2017 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QEX — Coronary 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 Coronary Vasculature Through Aspiration. |