Identifiers
- 510(k) Number
- K100826 FDA 510(k)
- FDA Product Code
- DQY 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 Catheter 025 is a catheter, percutaneous, designed for vascular access procedures. It features a variable stiffness, coil-reinforced shaft with a hydrophilic coating to enhance navigability. The device includes a PTFE-lined lumen for improved fluid flow, with a distal outer diameter of 0.040" and a proximal outer diameter of 0.045". Available in multiple tip configurations (straight, 45°, 90°, J), it is intended for use in peripheral and neurovascular applications.
This catheter is supplied as a single-use, non-sterile device and requires terminal sterilisation prior to use. It is classified under FDA regulation 870.1250 and falls under the Cardiovascular specialty. The device is intended for use in controlled clinical settings, such as interventional radiology or cardiology suites, where precise vascular access is required. No additional regulatory approvals beyond the FDA 510(k) clearance (K100826) are stated.
Frequently asked questions
What types of medical procedures is the Penumbra Catheter 025 specifically designed for, and where would it typically be used in a clinical setting?
The Penumbra Catheter 025 is designed for vascular access procedures, particularly in peripheral and neurovascular applications. Its variable stiffness, coil-reinforced shaft, and hydrophilic coating make it suitable for navigating through challenging blood vessels. It is intended for use in controlled clinical settings like interventional radiology or cardiology suites, where precise and reliable vascular access is critical.
Is the Penumbra Catheter 025 single-use or reusable, and what preparation is required before use?
The Penumbra Catheter 025 is supplied as a single-use, non-sterile device. Since it is not sterile out-of-the-box, terminal sterilization must be performed before use to ensure safety and efficacy in clinical procedures.
What tip configurations are available for the Penumbra Catheter 025, and how might they influence its use?
The Penumbra Catheter 025 comes in multiple tip configurations, including straight, 45°, 90°, and J-tips. These variations allow clinicians to select the most appropriate tip shape for specific vascular access needs, such as navigating tortuous vessels or achieving precise positioning in peripheral or neurovascular procedures.
What are the outer diameters of the Penumbra Catheter 025, and how might this affect its compatibility with other medical devices?
The Penumbra Catheter 025 has a distal outer diameter of 0.040 inches and a proximal outer diameter of 0.045 inches. These measurements ensure compatibility with standard vascular access systems and guidewire sizes, allowing for smooth integration into existing interventional workflows while maintaining flexibility and navigability.
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 CATHERER 025 (K100826) — FDA 510 (k) | Innolitics, PDF PENUMBRA CATHERER 025 510 (k) K100826 - FDA.report, PDF K100826 - Penumbra Catherer 025
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K100826 | Class II | Active |
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Manufacturer
- Manufacturer
- Penumbra, Inc.
Sources (1)
- FDA 510(k) K100826 24 fields · synced Sep 20, 2026