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bio-medicus cannula introducer
Bio Medicus
Summary: The Bio-Medicus Cannula Introducer is a medical device used primarily in cardiovascular procedures to facilitate the insertion of cannulas. It is typically used by cardiovascular surgeons and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K903410 ↗
Decision Date
October 31, 1990
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Bio-Medicus Cannula Introducer was cleared through the FDA 510k pathway on October 31, 1990. Manufactured by Bio Medicus, it is classified as a Class 2 device under product code DYB.
What It Is
The Bio-Medicus Cannula Introducer is a specialized tool designed to aid in the insertion of cannulas into blood vessels during surgical procedures. It is typically used in conjunction with other cardiovascular devices to ensure precise and safe placement of cannulas, which are critical for procedures such as cardiopulmonary bypass. The introducer helps minimize trauma to the vessel and surrounding tissues during insertion.
Clinical Applications
This device is commonly used in cardiovascular surgeries, particularly in settings where cardiopulmonary bypass is required, such as open-heart surgery. It is also utilized in interventional radiology for procedures that require vascular access. The typical patient population includes those undergoing complex cardiac surgeries or interventions requiring precise vascular access.
Indications for Use
The Bio-Medicus Cannula Introducer is indicated for use in procedures requiring the insertion of cannulas into blood vessels, particularly in cardiovascular surgeries. It is suitable for patients needing cardiopulmonary support or other interventions requiring vascular access.
Practical Considerations
The introducer is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard cannulas used in cardiovascular procedures. Clinicians should be familiar with the technique for using the introducer to minimize vessel trauma and ensure proper cannula placement.
Frequently Asked Questions
What is the Bio-Medicus Cannula Introducer used for?
It is used to facilitate the insertion of cannulas into blood vessels during cardiovascular procedures.
What specialties typically use this device?
Cardiovascular surgeons and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for use in procedures requiring cannula insertion into blood vessels, especially in cardiovascular surgeries.
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.