Identifiers
- 510(k) Number
- K161506 FDA 510(k)
- FDA Product Code
- QEW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5150 FDA 510(k)
- Regulation Number
- 870.5150 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Penumbra Aspiration System is a mechanical thrombectomy device designed to remove thrombus and restore blood flow in the neurovasculature using aspiration. It is a fully-integrated system for the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusions.
The Penumbra Aspiration System is supplied with components such as the Penumbra Reperfusion Catheters and the Penumbra Aspiration Pump, and is used in a cardiovascular setting. The system enables both continuous and modulated aspiration, and is regulated under FDA 510(k) with the product code QEW and regulation number 870.5150.
Frequently asked questions
What is the Penumbra Aspiration System used for?
The Penumbra Aspiration System is used to remove thrombus and restore blood flow in the neurovasculature of patients with acute ischemic stroke secondary to intracranial large vessel occlusions.
What components are included with the Penumbra Aspiration System?
The system is supplied with components such as the Penumbra Reperfusion Catheters and the Penumbra Aspiration Pump.
How is the Penumbra Aspiration System regulated?
The Penumbra Aspiration System is regulated under FDA 510(k) with the product code QEW and regulation number 870.5150.
In what setting is the Penumbra Aspiration System used?
The Penumbra Aspiration System is used in a cardiovascular setting.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Penumbra System | Penumbra Inc, Penumbra System | Penumbra Inc, Penumbra System (Thunderbolt Aspiration Tubing) (K250690) — FDA 510(k ..., Techniques and Results—Penumbra Aspiration Catheter
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161506 | Class II | Active |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (1)
- FDA 510(k) K161506 24 fields · synced Sep 25, 2026