đź“‹ FDA Reference
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Medtronic Vascular
Summary: The Affinity 38 Micro Arterial Blood Filter with Carmeda BioActive Surface is a medical device used in cardiovascular procedures to filter blood. It is typically used by cardiovascular surgeons and perfusionists during surgeries requiring cardiopulmonary bypass.
FDA Clearance Information
Pathway
510K
Number
K000379 ↗
Decision Date
February 16, 2000
Product Code
DTM
Device Class
Class 2
Evidence
0 studies
The Affinity 38 Micro Arterial Blood Filter was cleared through the FDA 510(k) pathway on February 16, 2000. It is manufactured by Medtronic Vascular and is classified as a Class 2 device.
What It Is
The Affinity 38 Micro Arterial Blood Filter is a device designed to filter arterial blood during cardiopulmonary bypass procedures. It features the Carmeda BioActive Surface, which helps reduce blood activation and improve biocompatibility. This filter is crucial in maintaining blood purity and minimizing embolic events during cardiac surgeries.
Clinical Applications
This device is commonly used in cardiac surgeries that require cardiopulmonary bypass, such as coronary artery bypass grafting (CABG) and valve replacement surgeries. It is typically utilized in hospital settings by cardiovascular surgeons and perfusionists to ensure the safety and efficacy of blood filtration during these complex procedures.
Indications for Use
The FDA-cleared indications suggest that this device is intended for use in patients undergoing procedures that require cardiopulmonary bypass. It is particularly suited for filtering blood to prevent embolic complications during cardiac surgeries.
Practical Considerations
The Affinity 38 Micro Arterial Blood Filter is compatible with standard cardiopulmonary bypass circuits. Clinicians should ensure proper integration into the bypass system and verify compatibility with other components. Proper handling and priming techniques are essential to maintain device efficacy.
Frequently Asked Questions
What is the Affinity 38 Micro Arterial Blood Filter used for?
It is used to filter arterial blood during cardiopulmonary bypass procedures to prevent embolic complications.
What specialties typically use this device?
Cardiovascular surgeons and perfusionists typically use this device during cardiac surgeries requiring cardiopulmonary bypass.
What are the FDA-cleared indications?
The device is indicated for use in filtering blood during cardiopulmonary bypass procedures in cardiac 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.