đź“‹ FDA Reference
apro 45 catheter
Alembic
Summary: The apro 45 catheter is a medical device used in venous stenting procedures. It is primarily used by interventional cardiologists and vascular surgeons to treat venous obstructions.
FDA Clearance Information
Pathway
510K
Number
K251014 ↗
Decision Date
May 1, 2025
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The apro 45 catheter received FDA clearance via the 510(k) pathway on May 1, 2025. It is manufactured by Alembic and classified as a Class 2 device under product code DQY.
What It Is
The apro 45 catheter is designed for use in venous stenting procedures. It facilitates the placement of stents in veins to treat obstructions or stenosis. The catheter is engineered to navigate the venous system efficiently, ensuring precise stent deployment. Its design supports compatibility with various stent types, offering flexibility in treatment options.
Clinical Applications
This catheter is commonly used in procedures involving venous stenting, particularly in patients with venous obstructions due to conditions like deep vein thrombosis or post-thrombotic syndrome. Interventional cardiologists and vascular surgeons typically use this device in hospital settings, especially in catheterization labs. It is suitable for adult patients experiencing symptoms related to venous insufficiency.
Indications for Use
The FDA-cleared indications for the apro 45 catheter involve its use in treating venous obstructions. It is intended for patients who require stenting to alleviate symptoms associated with venous blockages, such as swelling or pain in the affected limb.
Practical Considerations
The apro 45 catheter is available in various sizes to accommodate different patient anatomies. It is compatible with standard stent delivery systems and requires careful handling to ensure precise placement. Clinicians should be trained in catheter navigation and stent deployment techniques.
Related Literature
The linked study, 'Low-dose vs standard-dose unfractionated heparin for percutaneous coronary intervention in acute coronary syndromes treated with fondaparinux,' explored optimal heparin dosing during PCI in patients with acute coronary syndromes. The study found that low-dose heparin was as effective as standard-dose in preventing complications, with fewer bleeding events. However, the study's focus on coronary intervention limits its direct applicability to venous stenting contexts.
Frequently Asked Questions
What is apro 45 catheter used for?
The apro 45 catheter is used for venous stenting procedures to treat venous obstructions.
What specialties typically use this device?
Interventional cardiologists and vascular surgeons typically use the apro 45 catheter.
What are the FDA-cleared indications?
The device is indicated for treating venous obstructions requiring stenting to alleviate symptoms like swelling or pain.
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.