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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
510K
Number
K080849 ↗
Decision Date
July 25, 2008
Product Code
DQY
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.
Clinical Applications
These devices are commonly used in interventional radiology and vascular surgery settings. They are particularly useful in procedures aimed at treating conditions such as deep vein thrombosis or chronic venous insufficiency. The microsheath lp and lp-at are suitable for adult patients experiencing venous blockages that require stenting to improve blood flow.
Indications for Use
The FDA indications for the microsheath lp and lp-at involve their use in procedures that require venous stenting. This includes patients with narrowed or blocked veins that need to be opened to restore adequate circulation.
Practical Considerations
Clinicians should consider the compatibility of the microsheath lp and lp-at with the stents being used. The low-profile design aids in navigating through complex vascular pathways, and typical sizing should be selected based on the specific anatomical requirements of the patient.
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.