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Penumbra LP Coil System
Product: LP Coil System — all models and sizes
Summary: The Penumbra LP Coil System is a medical device used for mechanical thrombectomy in venous systems. It is typically utilized by interventional radiologists and vascular surgeons to remove blood clots.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K230284 ↗
Decision Date ?
October 25, 2023
Product Code ?
HCG Device, Neurovascular Embolization
Device Class ?
Class 2
Evidence ?
0 studies
The Penumbra LP Coil System was cleared through the FDA 510(k) pathway on October 25, 2023. It is manufactured by Penumbra and classified as a Class 2 device under product code HCG.
What It Is
The Penumbra LP Coil System is designed for mechanical thrombectomy, a procedure to remove blood clots from the venous system. It consists of coils that are delivered via a catheter to the site of the clot, where they help to capture and extract the thrombus. This system is particularly useful in cases where pharmacological thrombolysis is contraindicated or ineffective.
FDA-Cleared Indications
- Mechanical thrombectomy for removal of thrombus from the venous system.
Clinical Applications
- Catheter-based removal of thrombus from a vein when mechanical thrombectomy is clinically indicated.
- Endovascular venous thrombectomy performed with fluoroscopic imaging guidance.
- Use by trained endovascular teams as part of treatment for selected venous thrombotic disease.
Practical Considerations
- The system is available in different configurations and sizes; selection depends on vessel diameter, clot characteristics and the compatible delivery catheter.
- The procedure requires vascular access, catheter navigation and fluoroscopic guidance by clinicians trained in endovascular techniques.
- The FDA product-code description supports venous embolization or thrombectomy use; the specific cleared indication and device instructions for use should be reviewed before treatment.
- Risks may include bleeding at the access site, vessel injury, embolization of clot fragments, infection, contrast reaction and incomplete clot removal.
- MRI safety and conditional-use information must be confirmed in the current manufacturer labeling. Do not assume the device is MR safe without checking the device-specific instructions for use.
Procedures that use this device
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 the venous system, meaning it is used to remove blood clots from veins.
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.