Coronary Mechanical Thrombectomy With Aspiration
Device Code: 994
Product Code(s):
QEX Definition: To Mechanically Disrupt Thrombus And/or Debris Prior To Removal From The Coronary Vasculature Through Aspiration.
Device Classification Information
| Device Type ID | 994 |
| Device Name | Coronary Mechanical Thrombectomy With Aspiration |
| Physical State | Coronary Catheter |
| Technical Method | Remove Thrombus From Coronary Vasculature |
| Target Area | 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 | QEX |
| GMP Exempt | No |
| 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 | 994 |
| Device | Coronary Mechanical Thrombectomy With Aspiration |
| Product Code | QEX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Embolectomy Catheter. |
| CFR Regulation Number | 870.5150 [🔎] |
TPLC Last Update: 2019-04-02 19:45:59