K130536 is an FDA 510(k) clearance for the EXPORT ADVANCE ASPIRATION CATHETER. This device is classified as a Aspiration Thrombectomy Catheter (Class II - Special Controls, product code QEZ).
Submitted by Medtronic, Inc. (Danvers, US). The FDA issued a Cleared decision on July 16, 2013, 137 days after receiving the submission on March 1, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150. To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration..
| 510(k) Number | K130536 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2013 |
| Decision Date | July 16, 2013 |
| Days to Decision | 137 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QEZ — Aspiration Thrombectomy Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |
| Definition | To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration. |