ISO13485 Single-Use Cardioplegia Delivery System for Cardiopulmonary Bypass and Cardiac Surgery

The ISO13485 Single-Use Cardioplegia Delivery System is a specialized disposable perfusion component designed for open heart surgery, cardiopulmonary bypass (CPB) procedures and myocardial protection applications.

During cardiac surgery, controlled delivery of cardioplegia solution is essential to achieve effective cardiac arrest, reduce myocardial oxygen consumption and provide surgeons with a stable operating environment.

This single-use cardioplegia system provides a reliable solution for:

• Cardiopulmonary bypass procedures
• Open heart surgery
• Myocardial protection protocols
• Cardiac perfusion workflows
• Cardiovascular surgical research

Manufactured under an ISO 13485 quality management system, the system is designed for hospitals, cardiac surgery departments, perfusion teams, CPB equipment manufacturers and global medical device distributors.

During open heart surgery, the heart requires controlled protection to minimize metabolic demand and maintain myocardial viability.

A reliable cardioplegia delivery system helps deliver cardioplegia solution accurately and consistently.

Clinical benefits:

• Controlled cardiac arrest support
• Stable cardioplegia administration
• Improved surgical field conditions
• Optimized perfusion workflow

Traditional reusable surgical components require cleaning, sterilization and maintenance procedures.

The disposable cardioplegia delivery system provides:

• Individual sterile packaging
• No cleaning or reprocessing required
• Reduced contamination risk
• Simplified operating room preparation

Benefits for hospitals:

• Improved workflow efficiency
• Reduced instrument management workload
• Consistent product performance

Different cardiac centers may use different cardioplegia strategies.

The system is available in multiple configurations to support clinical requirements.

Designed for procedures using crystalloid cardioplegia solutions.

Applications:

• Standard cardiac surgery procedures
• Cardioplegia administration protocols

Advantages:

• Reliable fluid delivery
• Simple clinical workflow
• Consistent preparation process

Designed for blood cardioplegia protocols combining patient blood with cardioplegia solution.

Advantages:

• Supports blood cardioplegia techniques
• Flexible surgical application
• Adaptable to different perfusion strategies

The system is designed to provide a reliable pathway for cardioplegia solution delivery during extracorporeal circulation.

Advantages:

• Stable fluid flow
• Secure connection design
• Reduced preparation complexity
• Improved procedural reliability

The cardioplegia delivery system can be integrated into cardiac perfusion workflows together with:

• Cardiopulmonary bypass systems
• Perfusion circuits
• Blood management systems
• Cardiac surgery accessories

Designed to support efficient preparation before cardiac procedures.

Applications include:

• Valve replacement surgery
• Coronary artery bypass surgery (CABG)
• Congenital heart surgery
• Other cardiac procedures requiring cardioplegia protection

Benefits:

• Reliable cardioplegia administration
• Improved surgical workflow
• Consistent disposable solution

During CPB procedures, cardioplegia delivery plays an important role in myocardial protection.

Applications:

• Cardiac bypass surgery
• Perfusion procedures
• Cardiovascular surgical centers

Advantages:

• Supports perfusion protocols
• Easy system preparation
• Reliable clinical performance

The system can also support:

• Cardiac surgery research
• Perfusion studies
• Medical device evaluation

Cardiac surgery consumables require strict quality control and manufacturing consistency.

Our production system supports:

• Controlled manufacturing process
• Material inspection
• Production traceability
• Batch quality management

Providing reliable cardiac surgery components for hospitals and medical device partners worldwide.

We provide customized solutions for:

• Cardiac surgery distributors
• CPB equipment manufacturers
• Medical device companies
• Healthcare institutions

Customization options:

• Tubing configuration
• Component design
• Packaging requirements
• Private label solutions

• Reliable cardioplegia delivery
• Simplified surgical preparation
• Single-use infection control solution

• Compatible with CPB workflow
• Flexible configuration options
• Stable perfusion support component

• Growing cardiovascular surgery market
• ISO13485 manufacturing support
• OEM cooperation available

A cardioplegia delivery system is a disposable medical device set used during cardiac surgery to deliver cardioplegia solution for controlled cardiac arrest and myocardial protection.

It is mainly used for:

• Open heart surgery
• Cardiopulmonary bypass procedures
• Cardiovascular surgical applications

The single-use design helps reduce contamination risks, eliminate reprocessing requirements and improve surgical preparation efficiency.

The system supports:

• Crystalloid cardioplegia
• Blood + crystalloid cardioplegia

Yes. OEM customization including configuration, packaging and product requirements can be provided for medical device partners.

Schematic diagram

Standard Configuration

Single-used Cardioplegia Delivery System for Autotransfusion System