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apro 55 catheter
Alembic
Summary: The apro 55 catheter by Alembic is a Class 2 medical device used primarily in venous stenting procedures. It is commonly utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K234115 ↗
Decision Date
March 15, 2024
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The apro 55 catheter, manufactured by Alembic, received FDA clearance through the 510k pathway on March 15, 2024. It is classified as a Class 2 device under product code DQY.
What It Is
The apro 55 catheter is a specialized medical device designed for use in venous stenting procedures. It facilitates the placement of stents within veins to maintain patency and improve blood flow. The catheter's design allows for precise navigation and deployment of stents in the venous system, making it a valuable tool in managing venous obstructions.
Clinical Applications
This catheter is commonly used in procedures addressing venous insufficiency, deep vein thrombosis, or post-thrombotic syndrome. It is typically employed in hospital settings, particularly in interventional radiology suites or vascular surgery departments. The device is suitable for adult patients with compromised venous flow requiring stent placement to alleviate symptoms and prevent complications.
Indications for Use
The FDA-cleared indications for the apro 55 catheter include its use in procedures requiring venous stenting. It is intended for patients with conditions such as venous obstructions or insufficiencies that necessitate the placement of a stent to restore and maintain adequate blood flow.
Practical Considerations
The apro 55 catheter is available in various sizes to accommodate different patient anatomies and stent dimensions. It is compatible with standard stenting equipment and requires familiarity with catheter-based techniques for optimal use. Clinicians should ensure proper sizing and positioning to achieve the best outcomes.
Frequently Asked Questions
What is apro 55 catheter used for?
The apro 55 catheter is used for placing stents in veins to treat venous obstructions and improve blood flow.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the apro 55 catheter.
What are the FDA-cleared indications?
The apro 55 catheter is indicated for use in venous stenting procedures to treat 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.