K132155 is an FDA 510(k) clearance for the Merit ASAPLP Aspiration Catheter. This device is classified as a Aspiration Thrombectomy Catheter (Class II - Special Controls, product code QEZ).
Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on November 7, 2013, 118 days after receiving the submission on July 12, 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 | K132155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2013 |
| Decision Date | November 07, 2013 |
| 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. |