K163353 is an FDA 510(k) clearance for the Needle's Eye Snare Retrieval Set - 54cm. This device is classified as a Catheter, Embolectomy (Class II - Special Controls, product code DXE).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on July 11, 2017, 223 days after receiving the submission on November 30, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K163353 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 30, 2016 |
| Decision Date | July 11, 2017 |
| Days to Decision | 223 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXE — Catheter, Embolectomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |