Scimed 6 French Micro-Max Guide Catheter
Scimed
FDA Clearance Information
The Scimed 6 French Micro-Max Guide Catheter was cleared through the FDA 510(k) pathway on November 13, 1995. It is manufactured by Scimed and classified as a Class 2 device under product code DQY.
What It Is
FDA-Cleared Indications
- Percutaneous use as a catheter for guiding or delivering other medical devices within the vascular system.
- Use by trained clinicians during image-guided vascular procedures.
Clinical Applications
- Guiding interventional devices through the vascular system during catheter-based procedures.
- Providing conduit access for vascular diagnostic or therapeutic instruments.
- Use in hospital catheterization laboratories and interventional procedure suites when percutaneous vascular access is required.
Reported off-label uses
- Use as an access or support catheter during selected venous interventions, such as mechanical thrombectomy or venous stenting, when the specific application is not included in the available FDA indication text.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The catheter is 6 French; clinicians must confirm that its inner diameter, length, and curve are compatible with the guidewire and device being used.
- Use fluoroscopic or other appropriate imaging guidance and standard sterile catheterization technique.
- Inspect the catheter before use and handle it carefully to reduce the risk of kinking, vessel injury, air entry, thrombosis, or device separation.
- MRI safety is not established by the information provided here. Confirm the exact product labeling and MRI conditions before scanning a patient with the catheter in place.
- Contraindications and precautions depend on the procedure and patient; review the current manufacturer instructions for use, vascular access risks, bleeding risk, infection, contrast allergy, and anticoagulation status.
Procedures that use this device
Frequently Asked Questions
What is the Scimed 6 French Micro-Max Guide Catheter used for?
It is used to guide other medical devices into the vascular system, primarily for venous stent placement and other interventional procedures.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in catheterization labs.
What are the FDA-cleared indications?
The catheter is indicated for guiding devices into the venous system, particularly for procedures involving stent placement.