Penumbra Embolectomy Aspiration System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K121917 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 Embolectomy Aspiration System is a Peripheral Mechanical Thrombectomy With Aspiration device, designed to mechanically remove thrombi from blood vessels through aspiration. It is classified under cardiovascular medical devices and is intended for use in procedures where clot removal is necessary to restore blood flow. The system employs a specialized catheter to aspirate and extract emboli, facilitating revascularization in affected vascular regions.
This device is supplied as a sterile, single-use system and is regulated under FDA 510(k) clearance (K121917) as substantially equivalent to existing products. It is intended for use in clinical settings such as interventional radiology or neurointerventional procedures, where precise clot removal is critical. The system includes various catheter sizes and configurations, as referenced by the associated FEI numbers, and adheres to regulatory standards for medical devices in the cardiovascular specialty. Storage and handling follow standard sterile medical device protocols.
Frequently asked questions
What is the Penumbra Embolectomy Aspiration System used for?
The Penumbra Embolectomy Aspiration System is designed for mechanical removal of thrombi (blood clots) from blood vessels through aspiration. It is specifically intended for use in procedures where clot removal is critical to restore blood flow, such as in interventional radiology or neurointerventional settings. The system employs a specialized catheter to aspirate and extract emboli, facilitating revascularization in affected vascular regions.
How is the Penumbra Embolectomy Aspiration System supplied and what are its sterility and usage guidelines?
The system is supplied as a sterile, single-use device. This ensures safety and compliance with medical device standards, preventing cross-contamination and ensuring consistent performance. Sterility is maintained through standard medical device packaging and handling protocols, and it is intended for one-time use only in clinical settings.
What catheter sizes and configurations are available for the Penumbra Embolectomy Aspiration System?
The Penumbra Embolectomy Aspiration System includes a variety of catheter sizes and configurations, each referenced by unique FEI numbers. These variations allow clinicians to select the appropriate catheter based on the specific anatomical and procedural requirements, ensuring optimal performance for clot removal in different vascular regions.
How should the Penumbra Embolectomy Aspiration System be stored?
The system must be stored according to standard sterile medical device protocols. This includes keeping it in its original, unopened packaging in a clean, dry environment, protected from extreme temperatures, moisture, and direct sunlight. Proper storage ensures sterility and device integrity until use.
What regulatory clearance does the Penumbra Embolectomy Aspiration System hold?
The Penumbra Embolectomy Aspiration System has received FDA 510(k) clearance under the designation K121917. This clearance confirms that the device is substantially equivalent to legally marketed predicate devices and meets regulatory standards for safety and effectiveness in its intended use for mechanical thrombectomy with aspiration.
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 embolectomy aspiration system indigotm aspiration system, Penumbra System by Penumbra, Inc. - lavascular.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121917 | Class II | Active |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (1)
- FDA 510(k) K121917 24 fields · synced Oct 1, 2026