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unballoon non-occlusion modeling catheter
Lemaitre Vascular
Summary: The unballoon non-occlusion modeling catheter is a medical device used in vascular procedures, particularly for venous stenting. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K133026 ↗
Decision Date
December 31, 2013
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The unballoon non-occlusion modeling catheter was cleared through the FDA 510k pathway on December 31, 2013. Manufactured by Lemaitre Vascular, it is classified as a Class 2 device.
What It Is
The unballoon non-occlusion modeling catheter is designed for use in vascular procedures, particularly in the placement and modeling of venous stents. It allows for precise stent deployment without occluding blood flow, which is crucial in maintaining perfusion during the procedure. This device is particularly useful in complex vascular interventions where maintaining blood flow is critical.
Clinical Applications
This catheter is commonly used in interventional radiology and vascular surgery settings. It is particularly beneficial in procedures involving venous stents, where maintaining blood flow is essential. The device is suitable for use in patients requiring stent placement in venous systems, such as those with venous insufficiency or post-thrombotic syndrome.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures involving venous stents. It is particularly useful in patients who require stent placement in the venous system without interrupting blood flow.
Practical Considerations
The catheter is typically available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard vascular access equipment and requires careful handling to ensure proper placement and function.
Related Literature
The linked study compared the use of contrast media and low-molecular-weight dextran for frequency-domain optical coherence tomography (FD-OCT) image acquisition. It found that low-molecular-weight dextran could be a safer alternative to contrast media, potentially reducing the risk of renal impairment. However, the study was limited to coronary stented lesions and may not directly apply to all vascular procedures.
Frequently Asked Questions
What is the unballoon non-occlusion modeling catheter used for?
It is used for the placement and modeling of venous stents without occluding blood flow during vascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in their procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures involving venous stents, particularly where maintaining blood flow is important.
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.