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interface crystalloid cardioplegic filter model 70
Medical
Summary: The Interface Crystalloid Cardioplegic Filter Model 70 is a medical device used to filter crystalloid cardioplegia solutions during cardiac surgery. It is primarily used by cardiac surgeons and perfusionists.
FDA Clearance Information
Pathway
510K
Number
K861226 ↗
Decision Date
June 2, 1986
Product Code
KRJ
Device Class
Class 2
Evidence
0 studies
The Interface Crystalloid Cardioplegic Filter Model 70 was cleared through the FDA 510(k) pathway on June 2, 1986. It is manufactured by Medical and classified as a Class 2 device under product code KRJ.
What It Is
The Interface Crystalloid Cardioplegic Filter Model 70 is designed to filter crystalloid solutions used in cardioplegia, which is a technique to induce cardiac arrest during heart surgery. The filter helps remove particulates and potential contaminants from the solution, ensuring the safety and efficacy of the cardioplegia. This device is an essential component in cardiac surgery setups, contributing to the protection of myocardial tissue during procedures.
Clinical Applications
This device is commonly used in cardiac surgery, particularly during procedures that require cardioplegia to protect the heart muscle. It is used in operating rooms and cardiac surgery centers, primarily by cardiac surgeons and perfusionists. The patient population includes individuals undergoing open-heart surgery, such as coronary artery bypass grafting or valve replacement.
Indications for Use
The FDA indications suggest that this device is intended for use in filtering crystalloid cardioplegia solutions. It is suitable for patients undergoing cardiac surgery where cardioplegia is administered to protect the heart.
Practical Considerations
The Interface Crystalloid Cardioplegic Filter Model 70 is typically compatible with standard cardioplegia delivery systems. Clinicians should ensure proper connection and priming of the filter to avoid air embolism. Regular checks for filter integrity and flow rate are recommended during use.
Frequently Asked Questions
What is Interface Crystalloid Cardioplegic Filter Model 70 used for?
It is used to filter crystalloid cardioplegia solutions during cardiac surgery to ensure the safety and efficacy of the procedure.
What specialties typically use this device?
This device is typically used by cardiac surgeons and perfusionists in the field of cardiac surgery.
What are the FDA-cleared indications?
The device is indicated for use in filtering crystalloid cardioplegia solutions during cardiac surgery.
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.