K160593 is an FDA 510(k) clearance for the Indy OTW Vascular Retriever. This device is classified as a Device, Percutaneous Retrieval (Class II - Special Controls, product code MMX).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on September 2, 2016, 185 days after receiving the submission on March 1, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K160593 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2016 |
| Decision Date | September 02, 2016 |
| Days to Decision | 185 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 |