Coronary Mechanical Thrombectomy With Aspiration
The Coronary Mechanical Thrombectomy With Aspiration device is a cardiovascular catheter-based device designed to mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration, used during percutaneous coronary interventions for acute myocardial infarction or coronary thrombosis. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 870.5150 in the Cardiovascular specialty. The product code is QEX. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QEX
- Device Class
- FDA class 2
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
To mechanically disrupt thrombus and/or debris prior to removal from the coronary vasculature through aspiration.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K253407 | NeVa PV Thrombectomy Device | Nov 24, 2025 | Unknown | Vesalio, Inc. |
| K171493 | MegaVac Mechanical Thrombectomy System | Aug 10, 2017 | Substantially Equivalent | Capture Vascular, Inc. |
| K163618 | INDIGO Aspiration System | May 24, 2017 | Unknown | Penumbra, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.