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penumbra lp coil system
Penumbra
Summary: The Penumbra LP Coil System is a medical device used for mechanical thrombectomy in venous systems. It is primarily utilized by interventional radiologists and vascular surgeons to remove blood clots.
FDA Clearance Information
Pathway
510K
Number
K192955 ↗
Decision Date
November 20, 2019
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
The Penumbra LP Coil System was cleared through the FDA 510(k) pathway on November 20, 2019. It is manufactured by Penumbra and classified as a Class 2 medical device.
What It Is
The Penumbra LP Coil System is designed to assist in the removal of blood clots from the venous system. It operates by deploying a coil into the clot, allowing for mechanical retrieval. This device is part of a broader category of tools used in endovascular procedures to restore blood flow in cases of thrombosis.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly useful in treating patients with deep vein thrombosis (DVT) or other venous thromboembolic conditions. The system is employed in hospital settings where endovascular procedures are performed, often on patients who are at risk for complications from untreated clots.
Indications for Use
The FDA indications for the Penumbra LP Coil System involve its use in mechanical thrombectomy procedures to treat venous clots. It is indicated for patients with conditions like deep vein thrombosis where clot removal is necessary.
Practical Considerations
The Penumbra LP Coil System comes in various sizes to accommodate different vessel diameters. It is compatible with standard endovascular equipment and requires careful technique to ensure successful clot retrieval. Clinicians should be familiar with the device's deployment mechanism and retrieval process.
Frequently Asked Questions
What is the Penumbra LP Coil System used for?
It is used for mechanical thrombectomy to remove blood clots from the venous system.
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 mechanical thrombectomy in patients with venous clots, such as those with deep vein thrombosis.
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.