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cardiotomy reservoir cr-2000
Delta Medical Industries
Summary: The Cardiotomy Reservoir CR-2000 is a medical device used in cardiac surgery to collect and filter blood. It is primarily used by cardiovascular surgeons and perfusionists during procedures requiring cardiopulmonary bypass.
FDA Clearance Information
Pathway
510K
Number
K790116 ↗
Decision Date
February 8, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Cardiotomy Reservoir CR-2000 was cleared through the FDA 510k pathway on February 8, 1979, by Delta Medical Industries. It is classified as a Class III device under product code DTB.
What It Is
The Cardiotomy Reservoir CR-2000 is a component of the cardiopulmonary bypass circuit used during open-heart surgery. It collects blood from the surgical field and filters it to remove air bubbles and particulate matter before it is returned to the patient. The reservoir plays a crucial role in maintaining blood volume and ensuring the safety and efficacy of the bypass procedure.
Clinical Applications
This device is commonly used in cardiac surgeries that require cardiopulmonary bypass, such as coronary artery bypass grafting (CABG) and heart valve repair or replacement. It is typically employed in hospital settings by cardiovascular surgeons and perfusionists. The device is essential for maintaining hemodynamic stability and ensuring the safe reinfusion of blood during complex cardiac procedures.
Indications for Use
The Cardiotomy Reservoir CR-2000 is indicated for use in patients undergoing cardiac surgery that requires cardiopulmonary bypass. It is suitable for procedures where blood collection and filtration are necessary to maintain blood volume and quality.
Practical Considerations
The Cardiotomy Reservoir CR-2000 is designed to be compatible with standard cardiopulmonary bypass circuits. It is important to ensure proper sizing and integration into the circuit to optimize performance. Clinicians should be familiar with the setup and operation to ensure effective use during surgery.
Frequently Asked Questions
What is the Cardiotomy Reservoir CR-2000 used for?
It is used to collect and filter blood during cardiac surgeries that require cardiopulmonary bypass.
What specialties typically use this device?
Cardiovascular surgeons and perfusionists in cardiac surgery settings use this device.
What are the FDA-cleared indications?
It is indicated for use in cardiac surgeries requiring cardiopulmonary bypass to collect and filter blood.
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.