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Penumbra Catherer 025
Product: PX SLIM Delivery Microcatheter — all models and sizes
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 ?
510(k)
Number ?
K100826 ↗
Decision Date ?
July 13, 2010
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used for percutaneous removal of thrombus, or blood clot, from blood vessels.
- FDA-cleared under product code DQY, Catheter, Percutaneous, for use in vascular procedures.
Clinical Applications
- Percutaneous catheter-based removal of thrombus from occluded veins.
- Treatment of selected venous thrombotic occlusions when mechanical thrombectomy is clinically indicated.
- Use by trained clinicians during image-guided vascular procedures to restore blood flow through a vessel obstructed by clot.
Reported off-label uses
- Catheter-based treatment of selected pulmonary emboli may be performed with devices of this general catheter type, but the specific indication must be confirmed against the current FDA labeling and device instructions for use.
- Use in arterial thrombectomy or other non-labeled vascular applications should not be assumed to be cleared for this catheter and may be off-label.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The catheter must be selected and sized for the target vessel, thrombus burden, access route, and compatible guidewire or introducer sheath.
- The procedure is performed under fluoroscopic or other appropriate imaging guidance through vascular access, commonly from the femoral or jugular vein depending on the anatomy.
- Review the current manufacturer instructions for use for contraindications, warnings, compatible equipment, preparation, and handling requirements.
- MRI safety and conditional-use requirements depend on the exact device configuration and whether the catheter remains in the patient; confirm the current labeling before MRI.
- Potential procedural risks include bleeding or hematoma at the access site, vessel injury, residual or recurrent thrombosis, embolization, infection, contrast reaction, and complications related to sedation or anesthesia.
Procedures that use this device
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.