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cobe smarxt hvr 4000 surface modified hardshell venous reservoir filtered nonfiltered
Cobe Cardiovascular
Summary: The Cobe Smarxt HVR 4000 is a surface-modified hardshell venous reservoir used in cardiac surgery. It is designed for use by cardiovascular surgeons during procedures requiring cardiopulmonary bypass.
FDA Clearance Information
Pathway
510K
Number
K993001 ↗
Decision Date
December 3, 1999
Product Code
DTN
Device Class
Class 2
Evidence
0 studies
The Cobe Smarxt HVR 4000 was cleared through the FDA 510(k) pathway on December 3, 1999. Manufactured by Cobe Cardiovascular, it is classified as a Class 2 device under product code DTN.
What It Is
The Cobe Smarxt HVR 4000 is a venous reservoir used in extracorporeal circulation during cardiac surgery. It features a surface-modified hardshell design that helps reduce the risk of air embolism and improve blood handling. The device can be used with or without filtration, allowing flexibility based on surgical needs.
Clinical Applications
This device is commonly used in cardiac surgeries that require cardiopulmonary bypass, such as coronary artery bypass grafting (CABG) and valve replacement surgeries. It is typically utilized in hospital operating rooms by cardiovascular surgeons and perfusionists. The device is suitable for adult patients undergoing complex cardiac procedures.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring venous blood collection and filtration during cardiopulmonary bypass. It is particularly useful in surgeries where blood management and air embolism prevention are critical.
Practical Considerations
The Cobe Smarxt HVR 4000 is compatible with standard cardiopulmonary bypass systems. It is important to ensure proper integration with the perfusion circuit to maintain optimal blood flow and filtration. Clinicians should be familiar with the device's setup and operation to maximize its efficacy.
Frequently Asked Questions
What is Cobe Smarxt HVR 4000 used for?
It is used in cardiac surgeries requiring cardiopulmonary bypass to collect and filter venous blood.
What specialties typically use this device?
Cardiovascular surgeons and perfusionists in cardiac surgery settings use this device.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring venous blood collection and filtration during cardiopulmonary bypass.
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.