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ISO13485 Single-Use Cardioplegia Delivery System for Cardiopulmonary Bypass and Cardiac Surgery
Product Overview
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.
Key Applications
Cardiopulmonary bypass procedures
Open heart surgery
Myocardial protection protocols
Cardiac perfusion workflows
Cardiovascular surgical research
Clinical Benefits
Supporting Effective Myocardial Protection
Controlled cardiac arrest support
Stable cardioplegia administration
Improved surgical field conditions
Optimized perfusion workflow
Single-Use Design Advantages
Ready-to-Use Cardiac Surgery Consumable
Individual sterile packaging
No cleaning or reprocessing required
Reduced contamination risk
Simplified operating room preparation
Configuration Options
Crystalloid Cardioplegia Type
Designed for procedures using crystalloid cardioplegia solutions
Standard cardiac surgery procedures
Reliable fluid delivery with simple clinical workflow
Blood + Crystalloid Cardioplegia Type
Designed for blood cardioplegia protocols
Combines patient blood with cardioplegia solution
Flexible surgical application and adaptable perfusion strategies
Clinical Applications
Open Heart Surgery
Valve replacement surgery
Coronary artery bypass surgery (CABG)
Congenital heart surgery
Other cardiac procedures requiring cardioplegia protection
Cardiopulmonary Bypass (CPB)
Cardiac bypass surgery
Perfusion procedures
Cardiovascular surgical centers
Cardiovascular Research
Cardiac surgery research
Perfusion studies
Medical device evaluation
Product Specifications
Parameter
Specification
Product Type
Single-Use Cardioplegia Delivery System
Application
Cardiac Surgery / CPB
Primary Function
Cardioplegia Solution Delivery
Configuration
Crystalloid / Blood + Crystalloid
Usage
Disposable Single Use
Sterilization
EO Sterilization
Quality System
ISO 13485
Application Area
Myocardial Protection & Cardiac Perfusion
Quality Assurance
Manufactured Under ISO 13485 Quality Management System
Controlled manufacturing process
Material inspection
Production traceability
Batch quality management
OEM & Customization
We provide customized solutions for:
Cardiac surgery distributors
CPB equipment manufacturers
Medical device companies
Healthcare institutions
Customization options include tubing configuration, component design, packaging requirements, and private label solutions.
Schematic Diagram
Frequently Asked Questions
Q1: What is a cardioplegia delivery system?
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.
Q2: What procedures use this system?
It is mainly used for open heart surgery, cardiopulmonary bypass procedures, and cardiovascular surgical applications.
Q3: Why choose a single-use cardioplegia system?
The single-use design helps reduce contamination risks, eliminate reprocessing requirements and improve surgical preparation efficiency.
Q4: What cardioplegia solutions are supported?
The system supports crystalloid cardioplegia and blood + crystalloid cardioplegia configurations.
Q5: Can the system be customized?
Yes. OEM customization including configuration, packaging and product requirements can be provided for medical device partners.
Standard Configuration
Single-used Cardioplegia Delivery System for Autotransfusion System
Company Details
Bronze Gleitlager
,
Bronze Sleeve Bushings
and
Graphite Plugged Bushings
from Quality China Factory
Business Type:
Manufacturer,Distributor/Wholesaler
Year Established:
2010
Total Annual:
30,000,000-50,000,000
Employee Number:
200~300
Ecer Certification:
Verified Supplier
Established in 2010, Golead Medical Group Co.,Ltd is a professional medical equipment manufacturer supplying multiple products including ultrasound system (human and veterinary use, handheld and traditional type), veterinary patient monitor, veterinary anesthesia machine, veterinary infusion bump, R... Established in 2010, Golead Medical Group Co.,Ltd is a professional medical equipment manufacturer supplying multiple products including ultrasound system (human and veterinary use, handheld and traditional type), veterinary patient monitor, veterinary anesthesia machine, veterinary infusion bump, R...