K152335 is an FDA 510(k) clearance for the Export Advance Aspiration Catheter. This device is classified as a Catheter, Embolectomy (Class II - Special Controls, product code DXE).
Submitted by Medtronic, Inc. (Danvers, US). The FDA issued a Cleared decision on September 18, 2015, 30 days after receiving the submission on August 19, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K152335 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2015 |
| Decision Date | September 18, 2015 |
| Days to Decision | 30 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 |