K112382 is an FDA 510(k) clearance for the TERUMO ASPRIATION CATHETER. This device is classified as a Aspiration Thrombectomy Catheter (Class II - Special Controls, product code QEZ).
Submitted by Terumo Medical Corporation (Elkton, US). The FDA issued a Cleared decision on December 14, 2011, 118 days after receiving the submission on August 18, 2011.
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 | K112382 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2011 |
| Decision Date | December 14, 2011 |
| Days to Decision | 118 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. |