QEX — Coronary Mechanical Thrombectomy With Aspiration Class II
FDA product code QEX covers "Coronary Mechanical Thrombectomy With Aspiration", a Class II medical device regulated under 21 CFR 870.5150. Submissions are reviewed by the Cardiovascular panel. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QEX
- Device Class
- Class II
- Regulation Number
- 870.5150
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration.