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medtronic model 5401b test cable
Medtronic Vascular
Summary: The Medtronic Model 5401b Test Cable is a medical device used primarily for testing purposes in interventional procedures. It is typically utilized by healthcare professionals in vascular and interventional radiology settings.
FDA Clearance Information
Pathway 510K
Number K896632 ↗
Decision Date December 13, 1989
Product Code DTC
Device Class Class 2
Evidence 0 studies
The Medtronic Model 5401b Test Cable was cleared through the FDA 510(k) pathway on December 13, 1989. Manufactured by Medtronic Vascular, it is classified as a Class 2 device under product code DTC.
What It Is
The Medtronic Model 5401b Test Cable is a specialized cable used in the testing and calibration of medical devices, particularly those involved in vascular interventions. It ensures that devices such as IVC filters are functioning correctly before and during procedures. This cable plays a crucial role in maintaining the accuracy and safety of interventional devices.
Clinical Applications
This test cable is commonly used in procedures involving inferior vena cava (IVC) filter retrievals. It is essential in settings such as interventional radiology and vascular surgery, where precise device performance is critical. The cable is used by clinicians to verify the functionality of devices in real-time during patient procedures, ensuring optimal outcomes.
Indications for Use
The FDA indications for the Medtronic Model 5401b Test Cable pertain to its use in ensuring the proper function of devices used in IVC filter retrieval. It is suitable for patients undergoing procedures where device accuracy is paramount.
Practical Considerations
The Medtronic Model 5401b Test Cable is typically compatible with a range of vascular devices. Clinicians should ensure compatibility with specific devices prior to use. Proper handling and connection techniques are essential to maintain device integrity and performance.
Frequently Asked Questions
What is the Medtronic Model 5401b Test Cable used for?
It is used for testing and calibrating medical devices, particularly in vascular interventions, to ensure they function correctly.
What specialties typically use this device?
Interventional radiology and vascular surgery specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in ensuring the proper function of devices used in IVC filter retrieval procedures.
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.