Penumbra System ACE 68 Reperfusion Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161640 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 ACE 68 Reperfusion Catheter is a neurovascular aspiration catheter designed for thrombus retrieval. Classified as a catheter, thrombus retriever, it is intended for mechanical removal of clots in occluded intracranial vessels during acute ischemic stroke interventions.
This device is supplied as a single-use, sterile catheter and is used in conjunction with an aspiration pump. It is regulated under FDA 510(k) clearance (K161640) and falls under device class II (regulation number 870.1250). The catheter is intended for use in neurovascular procedures within a sterile environment, adhering to standard medical device safety and sterility protocols.
Frequently asked questions
What is the primary clinical use of the Penumbra System ACE 68 Reperfusion Catheter, and how does it function in a medical setting?
The Penumbra System ACE 68 Reperfusion Catheter is specifically designed for mechanical removal of clots (thrombi) in occluded intracranial blood vessels during acute ischemic stroke interventions. It functions by aspirating the clot through its lumen when used in conjunction with an aspiration pump, helping to restore blood flow to the affected area of the brain.
Is the Penumbra System ACE 68 Reperfusion Catheter intended for single-use or reusable applications, and what does this mean for sterility?
The Penumbra System ACE 68 Reperfusion Catheter is supplied as a single-use device, meaning it is intended for one-time use only. This design ensures sterility is maintained, as it is packaged and sterilized by the manufacturer for a single procedure, adhering to standard medical device safety protocols for neurovascular interventions.
How is the Penumbra System ACE 68 Reperfusion Catheter regulated, and what does this mean for healthcare providers?
The device is regulated under FDA 510(k) clearance (K161640) and falls under Class II (regulation number 870.1250), indicating it has been deemed substantially equivalent to a predicate device through a formal review process. This means healthcare providers can use it with confidence, as it meets established safety and performance standards for neurovascular aspiration catheters in acute stroke care.
What type of environment is required for using the Penumbra System ACE 68 Reperfusion Catheter, and why is this important?
The catheter is intended for use in a sterile environment, such as an operating room or catheterization lab, during neurovascular procedures. This requirement ensures patient safety by minimizing infection risks, as the device is designed for direct contact with blood vessels in the brain, where sterility is critical.
What distinguishes the Penumbra System ACE 68 Reperfusion Catheter from other thrombus retrieval devices in terms of its regulatory pathway?
The device follows a special 510(k) clearance pathway, reviewed by the FDA’s Cardiovascular (CV) advisory committee, which evaluates its safety and effectiveness for mechanical thrombus removal in intracranial vessels. This pathway ensures rigorous scrutiny, particularly for devices used in high-stakes procedures like acute stroke interventions, where precision and reliability are paramount.
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: ACE Reperfusion Catheters - Penumbra Inc, Penumbra System | Penumbra Inc, Penumbra System ACE 68 Reperfusion Catheter (K161064) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K161640 | Class II | Active |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (1)
- FDA 510(k) K161640 24 fields · synced Sep 19, 2026