đź“‹ FDA Reference
modification of maxima forte hollow fiber oxygenator with balance biocompatible surface with plasma resistent fiber m0
Medtronic Vascular
Summary: The Maxima Forte Hollow Fiber Oxygenator with Balance Biocompatible Surface is used in cardiopulmonary bypass procedures to oxygenate blood. It is primarily used by cardiac surgeons and perfusionists during open-heart surgeries.
FDA Clearance Information
Pathway
510K
Number
K984271 ↗
Decision Date
March 9, 1999
Product Code
DTZ
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on March 9, 1999, by Medtronic Vascular. It is classified as a Class 2 medical device under product code DTZ.
What It Is
The Maxima Forte Oxygenator is a medical device designed to oxygenate and remove carbon dioxide from the blood during cardiopulmonary bypass procedures. It features a hollow fiber design with a plasma-resistant fiber and a biocompatible surface to minimize blood damage and inflammatory responses. This device is crucial in maintaining appropriate blood gas levels during complex cardiac surgeries.
Clinical Applications
This oxygenator is commonly used in cardiac surgery settings, particularly during procedures that require cardiopulmonary bypass, such as coronary artery bypass grafting (CABG) and heart valve replacements. It is used by cardiac surgeons and perfusionists in operating rooms, ensuring the patient's blood is adequately oxygenated while the heart is stopped.
Indications for Use
The device is indicated for use in patients undergoing cardiac surgery where cardiopulmonary bypass is required. It is suitable for patients needing temporary blood oxygenation and carbon dioxide removal during surgical procedures.
Practical Considerations
The device is available in various sizes to accommodate different patient body sizes and blood flow requirements. It is compatible with standard cardiopulmonary bypass circuits. Clinicians should ensure proper priming and setup to prevent air embolism and ensure optimal performance.
Frequently Asked Questions
What is Maxima Forte Oxygenator used for?
It is used to oxygenate blood and remove carbon dioxide during cardiopulmonary bypass in cardiac surgeries.
What specialties typically use this device?
Cardiac surgeons and perfusionists in the field of cardiovascular surgery.
What are the FDA-cleared indications?
The device is indicated for use in cardiopulmonary bypass procedures requiring temporary blood oxygenation and carbon dioxide removal.
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.