📋 FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Use to facilitate the insertion of cannulas into blood vessels during surgical procedures.
- Use in procedures requiring vascular cannulation for cardiopulmonary support or other cardiovascular interventions.
Clinical Applications
- Facilitating placement of cannulas during cardiovascular surgery.
- Supporting vascular cannulation for procedures involving cardiopulmonary bypass.
- Helping position compatible cannulas when controlled vascular access is required.
Practical Considerations
- The appropriate introducer size should be selected for the cannula, target vessel, patient anatomy and planned procedure.
- Compatibility with the intended cannula and other procedural equipment should be confirmed before use.
- The device should be handled by clinicians trained in vascular cannulation to reduce vessel injury, bleeding and malposition.
- The available FDA record does not establish that this device is MRI safe or MRI conditional. MRI use should be avoided unless current manufacturer labeling provides specific conditions.
- Contraindications, sterility, reuse, storage and duration of use should be determined from the current device labeling and institutional protocol.
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.