đź“‹ FDA Reference
Workstation Femoral Intravascular Retrieval Set
Medical Engineering And Development Institute
Summary: The workstation femoral intravascular retrieval set is a medical device used for retrieving embolization coils from blood vessels. It is typically used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K902477 ↗
Decision Date ?
August 24, 1990
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The workstation femoral intravascular retrieval set was cleared via the FDA 510k pathway on August 24, 1990. It is manufactured by the Medical Engineering And Development Institute and classified as a Class 2 device.
What It Is
This device is a specialized tool designed for the retrieval of embolization coils from the femoral artery. It consists of a catheter-based system that allows clinicians to safely and effectively remove misplaced or detached coils from the vascular system. The device is engineered to navigate the vascular anatomy with precision, minimizing the risk of vascular injury during retrieval.
FDA-Cleared Indications
- Retrieval of embolization coils from the femoral artery or other accessible blood vessels.
- Removal of embolization coils that have migrated, detached, or been incorrectly positioned during a vascular procedure.
Clinical Applications
- Retrieval of a misplaced embolization coil during catheter-directed treatment.
- Retrieval of a detached or migrated coil from a large peripheral blood vessel.
- Endovascular management of a coil-related complication after embolization of an aneurysm or vascular abnormality.
Practical Considerations
- The set is intended for use by clinicians trained in catheter-based vascular procedures and familiar with fluoroscopic imaging and vascular anatomy.
- Device size and catheter compatibility should be selected according to the vessel diameter, coil location, and access route.
- The usual access site is the common femoral artery, although the target vessel and approach depend on the coil location and the patient’s anatomy.
- The supplied FDA record does not establish MRI safety; MRI compatibility should be confirmed in the current device labeling before scanning.
- Potential complications include vessel injury, bleeding at the access site, thrombosis, embolization, or incomplete retrieval. Contraindications and precautions should be reviewed in the manufacturer’s current instructions for use.
Procedures that use this device
Frequently Asked Questions
What is the workstation femoral intravascular retrieval set used for?
It is used for retrieving embolization coils from blood vessels, particularly in cases of coil migration or misplacement.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for retrieving embolization coils from the femoral artery and other large vessels.
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.