đź“‹ FDA Reference
miniclinic tm
Instromedix
Summary: The miniclinic tm by Instromedix is a medical device used for IVC filter retrieval. It is typically utilized by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway 510K
Number K771922 ↗
Decision Date November 2, 1977
Product Code DTC
Device Class Class 2
Evidence 0 studies
The miniclinic tm was cleared through the FDA 510k pathway on November 2, 1977. Manufactured by Instromedix, it is classified as a Class 2 device under product code DTC.
What It Is
The miniclinic tm is a specialized device designed for the retrieval of inferior vena cava (IVC) filters. These filters are used to prevent pulmonary embolism by trapping large clots. The device facilitates the safe and effective removal of these filters when they are no longer needed or if complications arise.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings. It is particularly relevant for patients who have had an IVC filter placed due to a high risk of pulmonary embolism and now require its removal. The procedure is typically performed in a hospital or outpatient surgical center.
Indications for Use
The miniclinic tm is indicated for use in patients who have previously had an IVC filter placed and now require its retrieval. This may be due to the resolution of the condition that necessitated the filter or complications related to the filter itself.
Practical Considerations
When using the miniclinic tm, it is important to consider the size and type of the IVC filter being retrieved to ensure compatibility. The procedure requires fluoroscopic guidance and should be performed by clinicians experienced in endovascular techniques.
Frequently Asked Questions
What is miniclinic tm used for?
The miniclinic tm is used for the retrieval of inferior vena cava (IVC) filters in patients who no longer need them or are experiencing complications.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use this device.
What are the FDA-cleared indications?
The device is indicated for the retrieval of IVC filters in patients who require their 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.