📋 FDA Reference
Microsheath LP and Lp-At
Flowcardia
Summary: The microsheath lp and lp-at by Flowcardia are medical devices used in venous stenting procedures. They are typically utilized by interventional radiologists and vascular surgeons to treat venous obstructions.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K080849 ↗
Decision Date ?
July 25, 2008
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The microsheath lp and lp-at received FDA clearance through the 510(k) pathway on July 25, 2008. Manufactured by Flowcardia, these devices are classified as Class 2 under product code DQY.
What It Is
The microsheath lp and lp-at are specialized sheaths designed for use in venous stenting procedures. They facilitate the insertion and placement of stents within the venous system, helping to restore proper blood flow in cases of venous obstruction. These devices are engineered to be low-profile, allowing for easier navigation through the vascular system.
FDA-Cleared Indications
- Used to provide percutaneous vascular access for the introduction of catheters and other interventional devices.
- Used during catheter-based procedures in which access to the vascular system is required.
- The FDA record identifies the devices as Class II percutaneous catheters under product code DQY.
Clinical Applications
- Obtaining percutaneous vascular access for endovascular procedures.
- Providing a conduit for introducing catheters, wires, and compatible interventional devices.
- Supporting venous stent-placement procedures when the sheath is compatible with the selected stent system.
- Maintaining access during image-guided vascular interventions.
Practical Considerations
- Select the sheath size and length based on the target vessel, access site, anatomy, and requirements of the devices being introduced.
- Confirm compatibility with the guidewires, catheters, stents, and other equipment planned for the procedure.
- Use fluoroscopic or other appropriate imaging guidance and follow the current manufacturer instructions for preparation, insertion, flushing, and removal.
- Potential access-related complications include bleeding, hematoma, infection, vessel injury, thrombosis, and embolization; patient-specific contraindications and precautions should be assessed before use.
- MRI safety and conditional-use information should be verified in the current product labeling. Do not assume MRI compatibility from the device name alone.
Procedures that use this device
Frequently Asked Questions
What is microsheath lp and lp-at used for?
These devices are used for facilitating venous stenting procedures to treat venous obstructions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use these devices.
What are the FDA-cleared indications?
The devices are indicated for use in procedures requiring venous stenting to address venous blockages.
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.