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certodyn raecg universal adapter
B. Braun Medical
Summary: The Certodyn RAECG Universal Adapter is a medical device used in conjunction with venous stents. It is primarily utilized by interventional radiologists and vascular surgeons to facilitate procedures involving venous access.
FDA Clearance Information
Pathway
510K
Number
K973371 ↗
Decision Date
November 24, 1997
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Certodyn RAECG Universal Adapter was cleared through the FDA 510(k) pathway on November 24, 1997. Manufactured by B. Braun Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Certodyn RAECG Universal Adapter is a specialized medical device designed to interface with venous stents. It serves as a connector or adapter that ensures compatibility and secure attachment between stents and other procedural equipment. This device is crucial in maintaining the integrity and functionality of venous stents during interventional procedures.
Clinical Applications
This device is commonly used in procedures involving the placement or maintenance of venous stents, particularly in patients with conditions such as deep vein thrombosis or chronic venous insufficiency. It is typically employed in hospital settings, especially in interventional radiology and vascular surgery departments. The adapter is essential for ensuring proper stent deployment and stability during these procedures.
Indications for Use
The FDA indications for the Certodyn RAECG Universal Adapter involve its use in conjunction with venous stents. It is intended for patients requiring venous stenting due to conditions like obstructive venous diseases or compromised venous flow.
Practical Considerations
Clinicians should ensure compatibility of the adapter with the specific venous stents being used. The device is typically available in standard sizes to fit common stent models. Proper technique during attachment is crucial to prevent dislodgement or malfunction during procedures.
Frequently Asked Questions
What is the Certodyn RAECG Universal Adapter used for?
It is used to facilitate the connection and secure attachment of venous stents during interventional procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use with venous stents in patients with obstructive venous diseases or compromised venous flow.
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.