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Giant Lumen Safetip Series Endomyocardial Biopsy
Intec Medical
Summary: The Giant Lumen Safetip Series Endomyocardial Biopsy is a medical device used for obtaining tissue samples from the heart muscle. It is primarily used by cardiologists in hospital settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K903840 ↗
Decision Date ?
October 16, 1990
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
This device was cleared through the FDA 510(k) pathway on October 16, 1990. It is manufactured by Intec Medical and is classified as a Class 2 device under product code DYB.
What It Is
The Giant Lumen Safetip Series Endomyocardial Biopsy device is designed to safely obtain biopsy samples from the endomyocardial tissue. It features a large lumen for sample collection and a safetip design to minimize procedural risks. This device is typically used during cardiac catheterization procedures to diagnose conditions such as myocarditis or to monitor heart transplant rejection.
FDA-Cleared Indications
- Obtaining tissue specimens from the endomyocardium for histologic examination.
- Performing endomyocardial biopsy during cardiac catheterization when myocardial tissue sampling is clinically indicated.
Clinical Applications
- Endomyocardial biopsy for microscopic evaluation of heart muscle tissue.
- Sampling the right-sided heart muscle through catheter-based cardiac access when tissue diagnosis is needed.
- Obtaining myocardial specimens in the evaluation of suspected inflammatory or other myocardial disease, when ordered by the treating physician.
Practical Considerations
- The device is used by clinicians trained in cardiac catheterization and endomyocardial biopsy.
- Available sizes may vary; the operator selects the appropriate size and configuration for the patient’s anatomy and sampling requirements.
- Use requires imaging guidance and compatibility with the cardiac catheterization laboratory equipment and access system.
- The procedure has potential risks, including bleeding, vascular injury, arrhythmia, cardiac perforation, pericardial effusion or tamponade, infection, and inadequate tissue sampling.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; do not assume the device is MRI safe while it is in place.
Frequently Asked Questions
What is the Giant Lumen Safetip Series Endomyocardial Biopsy used for?
It is used to obtain tissue samples from the heart muscle for diagnostic purposes, such as assessing myocarditis or monitoring heart transplant rejection.
What specialties typically use this device?
This device is primarily used by cardiologists, especially those specializing in interventional cardiology and cardiac surgery.
What are the FDA-cleared indications?
The device is indicated for obtaining endomyocardial tissue samples to diagnose or monitor heart conditions like myocarditis or transplant rejection.
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.