đź“‹ FDA Reference
Penumbra LP Coil System
Product: Smart Coil — all models and sizes
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 ?
510(k)
Number ?
K192955 ↗
Decision Date ?
November 20, 2019
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 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.
FDA-Cleared Indications
- Intended for use in the neurovascular system for the removal of thrombus or foreign material during endovascular procedures.
- Use is limited to the specific device configurations, anatomy, and procedural conditions described in the FDA-cleared labeling and instructions for use.
Clinical Applications
- Catheter-based retrieval of thrombus in selected neurovascular procedures.
- Removal of foreign material from the neurovascular system during an endovascular procedure.
- Use by trained specialists when mechanical retrieval is appropriate and consistent with the device instructions for use.
Practical Considerations
- The FDA product code identifies this as a neurovascular embolization device; the available record does not support labeling it as a general venous thrombectomy device for DVT, pulmonary embolism, or dialysis-access thrombosis.
- Available sizes, catheter compatibility, deployment technique, and vessel limitations depend on the specific configuration and must be verified in the current instructions for use.
- The device should be handled under fluoroscopic or other appropriate imaging guidance by clinicians trained in endovascular neurovascular procedures.
- MRI safety depends on the exact device configuration and labeling. Confirm MR Safe, MR Conditional, or MR Unsafe status in the current manufacturer instructions before MRI.
- Contraindications, warnings, and risks may include vessel injury, perforation, dissection, embolization, bleeding, thrombosis, infection, and incomplete retrieval; clinicians should follow the current FDA-cleared labeling.
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.