QEX · Coronary Mechanical Thrombectomy With Aspiration
Cardiovascular · 21 CFR 870.5150 · Class 2
Overview
| Product Code | QEX |
|---|---|
| Device Name | Coronary Mechanical Thrombectomy With Aspiration |
| Regulation | 21 CFR 870.5150 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253407 | NeVa PV Thrombectomy Device | Vesalio, Inc. | Nov 24, 2025 | SESU |
| K171493 | MegaVac Mechanical Thrombectomy System | Capture Vascular, Inc. | Aug 10, 2017 | SESE |
| K163618 | INDIGO Aspiration System | Penumbra, Inc. | May 24, 2017 | SESU |
Top Applicants
- Capture Vascular, Inc. — 1 clearance
- Penumbra, Inc. — 1 clearance
- Vesalio, Inc. — 1 clearance
