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penumbra catherer 025
Penumbra
Summary: The Penumbra Catheter 025 is a medical device used for mechanical thrombectomy in venous procedures. It is primarily utilized by interventional radiologists and vascular surgeons to remove clots from veins.
FDA Clearance Information
Pathway
510K
Number
K100826 ↗
Decision Date
July 13, 2010
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Penumbra Catheter 025 was cleared through the FDA 510k pathway on July 13, 2010. Manufactured by Penumbra, it is classified as a Class 2 device under product code DQY.
What It Is
The Penumbra Catheter 025 is a specialized catheter designed for mechanical thrombectomy procedures. It works by navigating through the vascular system to reach and remove thrombi or clots from veins. The device is engineered to provide optimal flexibility and support, allowing clinicians to effectively restore blood flow in occluded vessels.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings. It is particularly valuable in treating patients with deep vein thrombosis or other venous occlusions. The device is suitable for use in hospitals and specialized clinics, where rapid intervention is necessary to prevent complications from venous thromboembolism.
Indications for Use
The FDA-cleared indications for the Penumbra Catheter 025 include use in procedures aimed at removing blood clots from veins. It is intended for patients experiencing venous blockages, often due to conditions like deep vein thrombosis.
Practical Considerations
The Penumbra Catheter 025 is typically compatible with standard guidewires and introducer sheaths. Clinicians should be familiar with catheter navigation techniques and ensure proper sizing for the target vessel to maximize procedural success.
Frequently Asked Questions
What is the Penumbra Catheter 025 used for?
The Penumbra Catheter 025 is used for mechanical thrombectomy to remove blood clots from veins.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for removing clots from veins in patients with venous occlusions.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.