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bio-medicus percutaneous cannula introducer set
Bio Medicus
Summary: The Bio-Medicus Percutaneous Cannula Introducer Set is a medical device used for introducing cannulas into the venous system. It is primarily used by cardiovascular surgeons and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K884129 ↗
Decision Date
December 21, 1988
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Bio-Medicus Percutaneous Cannula Introducer Set was cleared through the FDA 510k pathway on December 21, 1988. Manufactured by Bio Medicus, it is classified as a Class 2 device under product code DQY.
What It Is
The Bio-Medicus Percutaneous Cannula Introducer Set is designed to facilitate the insertion of cannulas into the venous system, typically during procedures requiring extracorporeal circulation. The set includes components that allow for percutaneous access, minimizing the need for surgical cutdowns. This device is crucial in procedures where quick and reliable venous access is needed, such as in cardiopulmonary bypass or ECMO (extracorporeal membrane oxygenation).
Clinical Applications
This device is commonly used in cardiac surgery and critical care settings, particularly in procedures involving extracorporeal circulation like ECMO or cardiopulmonary bypass. It is utilized by cardiovascular surgeons and interventional radiologists to ensure efficient venous access. The device is suitable for adult patients requiring temporary circulatory support or undergoing complex cardiac procedures.
Indications for Use
The FDA indications suggest that this device is intended for patients requiring percutaneous venous access for procedures like ECMO or cardiopulmonary bypass. It is particularly useful in situations where rapid and reliable venous access is critical.
Practical Considerations
The Bio-Medicus Percutaneous Cannula Introducer Set typically comes in various sizes to accommodate different patient anatomies. Compatibility with standard venous cannulas is generally ensured. Clinicians should be familiar with percutaneous insertion techniques to optimize outcomes and minimize complications.
Frequently Asked Questions
What is the Bio-Medicus Percutaneous Cannula Introducer Set used for?
It is used for introducing cannulas into the venous system, primarily in procedures like ECMO or cardiopulmonary bypass.
What specialties typically use this device?
Cardiovascular surgeons and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for percutaneous venous access in procedures requiring extracorporeal circulation, such as ECMO or 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.