K101839 is an FDA 510(k) clearance for the KANEKA PHARMA AMERICA XPRESS-WAY RX. This device is classified as a Aspiration Thrombectomy Catheter (Class II - Special Controls, product code QEZ).
Submitted by Kaneka Pharma America, LLC (Hudson, US). The FDA issued a Cleared decision on October 22, 2010, 113 days after receiving the submission on July 1, 2010.
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 | K101839 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2010 |
| Decision Date | October 22, 2010 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| 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. |