FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40
FDA Clearance Information
FDA-Cleared Indications
- For use in the peripheral vasculature to facilitate the placement and positioning of compatible catheters.
- For use during diagnostic angiographic and interventional procedures that require guide-wire access.
- For single-patient use by trained healthcare professionals in accordance with the device labeling.
Clinical Applications
- Catheter placement during peripheral angiography
- Guide-wire access for peripheral endovascular interventions
- Catheter exchanges within peripheral blood vessels
- Navigation through peripheral vascular anatomy under fluoroscopic or other appropriate imaging guidance
Reported off-label uses
- Guide-wire support during uterine-artery embolization
- Guide-wire support during internal-iliac-artery embolization
- Guide-wire support during peripheral balloon angioplasty
- Guide-wire support during selected neurointerventional procedures when the wire's labeling, dimensions, and compatibility are appropriate
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 listed models include F-14 and F-18 configurations with Flex, DP, SP, and tapered-tip designs; the numbers 25 and 40 generally identify specified wire lengths or configuration dimensions in the product line, which should be confirmed in the current labeling.
- Select the wire diameter, tip shape, stiffness, and length according to the access site, target vessel, catheter compatibility, and procedure.
- Use with compatible catheters and introducer systems; confirm the wire's usable length and compatibility before insertion.
- Advance and withdraw under imaging guidance without forcing the wire. Resistance, vessel tortuosity, spasm, or calcification can increase the risk of dissection, perforation, or wire damage.
- MRI safety should be determined from the current manufacturer labeling for the exact model. Do not assume the wire is MR Safe or MR Conditional based only on its FDA classification; retain the device labeling and check for contraindications, warnings, and single-use requirements.
Procedures that use this device
Frequently Asked Questions
What is the FMD Peripheral Guide Wire used for?
It is used to help place, position, and exchange compatible catheters in the peripheral vasculature during angiography and endovascular procedures. Use must follow the device's FDA-cleared labeling and manufacturer instructions.
What sizes are available for the FMD Peripheral Guide Wire?
The listed product family includes F-14 Flex 6, F-14 Tapered 40, F-18 Flex SP, F-18 DP 25, and F-18 Tapered 40. Exact diameters, lengths, tip designs, and compatibility should be confirmed in the current product labeling.
Is the FMD Peripheral Guide Wire MRI safe?
MRI status is model-specific and should be verified in the current manufacturer labeling. Do not use it in or near an MRI scanner unless the exact model is identified as MR Safe or MR Conditional and all conditions are met.
How long does a peripheral guide wire last?
This is a single-use device and is not intended to be reused or resterilized. Its duration in the body depends on the procedure and should follow the physician's plan and the device labeling.
How much does the FMD Peripheral Guide Wire cost?
The price varies by model, contract, facility, and distributor, and FDA records generally do not list a patient-specific cost. Patients should ask the hospital or procedure center whether the device is included in the procedure charge and what insurance will cover.