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Coronary Mechanical Thrombectomy With Aspiration

FDA product code QEX · 3 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.5150
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-05-24 – 2025-11-24

To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration.

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