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apro 55 intermediate catheter
Alembic
Summary: The apro 55 intermediate catheter is a medical device used primarily in vascular procedures, particularly for venous stenting. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K250962 ↗
Decision Date
April 29, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The apro 55 intermediate catheter, manufactured by Alembic, received FDA clearance through the 510(k) pathway on April 29, 2025. It is classified as a Class 2 device under product code DQY.
What It Is
The apro 55 intermediate catheter is designed for use in vascular interventions, particularly for the placement of venous stents. It facilitates the navigation and delivery of stents within the venous system. The catheter's design allows for flexibility and precision, aiding clinicians in accessing difficult-to-reach areas within the vascular anatomy.
Clinical Applications
This catheter is commonly used in procedures involving the treatment of venous obstructions or insufficiencies. It is particularly useful in settings such as interventional radiology suites and vascular surgery centers. The device is suitable for adult patients who require venous stenting, often due to conditions like deep vein thrombosis or chronic venous insufficiency.
Indications for Use
The apro 55 intermediate catheter is indicated for use in patients requiring venous stenting. It is designed to assist in the delivery and placement of stents within the venous system, addressing conditions like venous blockages or narrowing.
Practical Considerations
Clinicians should consider the catheter's compatibility with various stent sizes and types. It is important to follow proper technique to ensure successful navigation through the venous system. The catheter is typically available in various lengths to accommodate different anatomical requirements.
Frequently Asked Questions
What is apro 55 intermediate catheter used for?
It is used for the delivery and placement of venous stents during vascular interventions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The catheter is indicated for use in venous stenting procedures, particularly for addressing venous obstructions or insufficiencies.
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.