📋 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 ?
510(k)
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.
FDA-Cleared Indications
- Retrieval of an inferior vena cava filter that has previously been placed in a patient.
- Removal of an IVC filter when the original indication for filtration has resolved or retrieval is clinically indicated.
Clinical Applications
- Endovascular retrieval of a previously implanted IVC filter.
- Fluoroscopy-guided IVC filter removal through a venous access site.
- Removal of an IVC filter after the risk of pulmonary embolism has decreased, when retrieval is clinically appropriate.
- Retrieval of an IVC filter when filter-related complications or other clinical concerns require removal.
Practical Considerations
- Confirm that the device is compatible with the specific IVC filter model, retrieval hook or attachment point, and filter position.
- The procedure requires fluoroscopic imaging and should be performed by clinicians experienced in venous access and endovascular device retrieval.
- Evaluate the filter for tilt, embedment, fracture, migration, clot burden, or caval wall penetration before attempting retrieval; these findings may affect technique or eligibility.
- Review the device-specific labeling for size limits, deployment or retrieval technique, contraindications, and any MRI-related information. MRI safety cannot be determined from the FDA record alone.
- Potential risks of IVC filter retrieval include bleeding, infection, venous injury, caval perforation, filter fracture or embolization, thrombosis, and failure to remove the filter.
Procedures that use this device
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.