K170987 is an FDA 510(k) clearance for the Captus Vascular Retrieval System. This device is classified as a Device, Percutaneous Retrieval (Class II - Special Controls, product code MMX).
Submitted by Avantec Vascular Corporation (Sunnyvale, US). The FDA issued a Cleared decision on August 28, 2017, 147 days after receiving the submission on April 3, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K170987 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2017 |
| Decision Date | August 28, 2017 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MMX - Device, Percutaneous Retrieval |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |