Identifiers
- 510(k) Number
- K113163 FDA 510(k)
- FDA Product Code
- NRY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Penumbra System MAX is a Catheter, Thrombus Retriever, designed for mechanical thrombectomy to remove thrombi from vascular systems. It employs aspiration technology to clear occlusions in large vessels, facilitating revascularization in neurovascular and peripheral interventions.
This device is supplied as a reusable system paired with single-use reperfusion catheters (e.g., RED, JET, ACE) and operates under FDA 510(k) clearance (K113163) as a Class II medical device (regulation 870.1250). It is intended for use in controlled clinical settings, with compatibility confirmed for MRI-safe environments where applicable. Sterility and maintenance protocols are manufacturer-specified for reusable components.
Frequently asked questions
What types of vascular occlusions is the Penumbra System MAX designed to address, and how does it differ from other thrombectomy devices?
The Penumbra System MAX is specifically designed for mechanical thrombectomy to remove thrombi (blood clots) from large vessels, enabling revascularization in both neurovascular and peripheral interventions. Unlike some devices that rely solely on mechanical aspiration or embolic capture, this system combines aspiration technology with single-use reperfusion catheters (like RED, JET, or ACE) to efficiently clear occlusions. Its design emphasizes large-vessel applications, making it suitable for complex cases where clot removal must be thorough and precise.
Is the Penumbra System MAX reusable, and if so, what maintenance or sterility protocols must be followed for the reusable components?
Yes, the Penumbra System MAX is supplied as a reusable system, while the reperfusion catheters (e.g., RED, JET, ACE) are single-use. The reusable components require manufacturer-specified maintenance and sterility protocols to ensure safety and functionality. These protocols typically include cleaning, sterilization, and inspection procedures to prevent contamination or damage between uses, as outlined in Penumbra’s guidelines.
Can the Penumbra System MAX be used in MRI-safe environments, and if so, what considerations should clinicians keep in mind?
Yes, the Penumbra System MAX is designed with compatibility for MRI-safe environments where applicable. However, clinicians should verify the specific MRI safety guidelines for the reusable components and single-use catheters, as compatibility may vary depending on the materials and construction. Always follow the manufacturer’s instructions to ensure safe use in MRI settings, including any restrictions on imaging sequences or field strength.
What are the key differences between the Penumbra System MAX and other thrombectomy devices in terms of catheter compatibility and system flexibility?
The Penumbra System MAX pairs with a variety of single-use reperfusion catheters (e.g., RED, JET, ACE), offering flexibility to address different clinical scenarios. This modular approach allows clinicians to select catheters optimized for specific vessel sizes or clot characteristics, unlike some systems that rely on a single catheter design. The aspiration-based technology of the System MAX also distinguishes it from purely mechanical retrieval devices, providing a balance between clot fragmentation and efficient removal.
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 system max, Access catheter - Penumbra System® MAX™ - Penumbra - occlusion ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K113163 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (1)
- FDA 510(k) K113163 24 fields · synced Sep 19, 2026