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stockert-shiley caps hlm interface
Shiley
Summary: The Stockert-Shiley CAPS HLM Interface is a medical device used in cardiac surgery to interface with heart-lung machines. It is primarily used by cardiac surgeons and perfusionists during procedures requiring cardiopulmonary bypass.
FDA Clearance Information
Pathway
510K
Number
K863541 ↗
Decision Date
November 18, 1986
Product Code
DTQ
Device Class
Class 2
Evidence
0 studies
The Stockert-Shiley CAPS HLM Interface was cleared through the FDA 510k pathway on November 18, 1986. Manufactured by Shiley, it is classified as a Class 2 device under product code DTQ.
What It Is
The Stockert-Shiley CAPS HLM Interface is designed to facilitate the connection between heart-lung machines and patient circuits during cardiac surgery. It ensures efficient and safe management of blood flow and oxygenation when the heart is temporarily stopped. The device plays a critical role in maintaining hemodynamic stability and oxygen delivery during complex cardiac procedures.
Clinical Applications
This device is commonly used in cardiac surgery settings, particularly during procedures that require cardiopulmonary bypass, such as coronary artery bypass grafting (CABG) and heart valve repair or replacement. It is utilized by cardiac surgeons and perfusionists in operating rooms equipped with heart-lung machines. The device is essential for adult and pediatric patients undergoing open-heart surgery.
Indications for Use
The FDA indications for the Stockert-Shiley CAPS HLM Interface include its use in procedures requiring cardiopulmonary bypass, where it serves as a critical component in managing extracorporeal circulation. It is indicated for patients undergoing surgeries that necessitate temporary heart and lung function support.
Practical Considerations
Clinicians should consider compatibility with existing heart-lung machines and ensure proper sizing for the patient population being treated. Familiarity with the interface's setup and operation is crucial for seamless integration into surgical workflows.
Frequently Asked Questions
What is the Stockert-Shiley CAPS HLM Interface used for?
It is used to connect heart-lung machines to patient circuits during cardiac surgeries requiring cardiopulmonary bypass.
What specialties typically use this device?
Cardiac surgeons and perfusionists in cardiac surgery settings typically use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring cardiopulmonary bypass, such as open-heart surgeries.
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.