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attain assist cs access catheter
Creganna Medical Also Doing Business As Ceganna Tactx Medica
Summary: The Attain Assist CS Access Catheter is a medical device used for accessing the coronary sinus in cardiac procedures. It is typically used by cardiologists in interventional settings.
FDA Clearance Information
Pathway
510K
Number
K171819 ↗
Decision Date
January 4, 2018
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Attain Assist CS Access Catheter was cleared through the FDA 510k pathway on January 4, 2018. Manufactured by Creganna Medical, it is classified as a Class 2 device.
What It Is
The Attain Assist CS Access Catheter is a specialized catheter designed to facilitate access to the coronary sinus, a large vein in the heart. It is used in procedures that require precise navigation and placement of devices within the venous system, particularly during cardiac resynchronization therapy. The catheter's design allows for improved maneuverability and stability, aiding clinicians in effectively reaching target areas within the heart.
Clinical Applications
This catheter is commonly used in electrophysiology labs and interventional cardiology settings. It is essential for procedures such as cardiac resynchronization therapy (CRT) where precise placement of leads in the coronary sinus is required. The device is particularly useful in patients with heart failure who are candidates for CRT, and it is primarily utilized by cardiologists and electrophysiologists.
Indications for Use
The FDA indications for the Attain Assist CS Access Catheter involve its use in accessing the coronary sinus for cardiac procedures. It is intended for patients requiring interventions that involve the placement of devices in the heart's venous system, such as those undergoing CRT.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and procedural needs. Clinicians should ensure compatibility with other devices used during the procedure, such as guidewires and leads. Proper technique in handling and navigating the catheter is crucial for successful outcomes.
Frequently Asked Questions
What is the Attain Assist CS Access Catheter used for?
It is used for accessing the coronary sinus during cardiac procedures, particularly for cardiac resynchronization therapy.
What specialties typically use this device?
Cardiologists and electrophysiologists in interventional cardiology and electrophysiology settings typically use this device.
What are the FDA-cleared indications?
The device is indicated for accessing the coronary sinus in cardiac procedures, especially for placing devices like leads during cardiac resynchronization therapy.
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.