đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use as a venous reservoir in extracorporeal circulation systems during procedures requiring cardiopulmonary bypass.
- Use for collection and management of venous blood within a cardiopulmonary bypass circuit.
- Use in filtered or nonfiltered configurations, according to the selected device configuration and circuit requirements.
Clinical Applications
- Venous blood collection during cardiopulmonary bypass for open cardiac surgery.
- Blood management during coronary artery bypass grafting when cardiopulmonary bypass is used.
- Blood management during cardiac valve repair or replacement when cardiopulmonary bypass is used.
- Integration into a hospital perfusion circuit requiring a rigid venous reservoir, with or without filtration.
Practical Considerations
- The device must be incorporated into a compatible cardiopulmonary bypass circuit and used by trained cardiovascular surgery and perfusion personnel.
- Confirm the exact model configuration, including filtered or nonfiltered design, connection ports, priming volume, and flow specifications, using the current manufacturer labeling.
- This is a blood-contacting extracorporeal circuit component; careful priming, de-airing, monitoring of reservoir volume, and inspection for leaks or damage are required.
- The reservoir is not an implanted device and is not intended for direct vascular implantation or long-term indwelling use.
- MRI safety should not be assumed. Because the device is used as part of an extracorporeal circuit during surgery, consult the current manufacturer labeling and institutional MRI safety policy before bringing it into an MRI environment.
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.