Aspiration Thrombectomy Catheter
Device Code: 996
Product Code(s):
QEZ Definition: To Remove Thrombus From The Peripheral And/or Coronary Vasculature Through Aspiration.
Device Classification Information
| Device Type ID | 996 |
| Device Name | Aspiration Thrombectomy Catheter |
| Physical State | Peripheral And/or Coronary Catheter |
| Technical Method | Removed Thrombus From The Vasculature |
| Target Area | Peripheral And/or Coronary Vasculature |
| Regulation Description | Embolectomy Catheter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.5150 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | QEZ |
| GMP Exempt | Yes |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 996 |
| Device | Aspiration Thrombectomy Catheter |
| Product Code | QEZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Embolectomy Catheter. |
| CFR Regulation Number | 870.5150 [🔎] |
TPLC Last Update: 2019-04-02 19:46:01