đź“‹ FDA Reference
Micropuncture Pedal Access Set
Summary: The micropuncture pedal access set by Cook is a medical device used for vascular access in the lower extremities, particularly for procedures like embolization. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K172980 ↗
Decision Date ?
May 3, 2018
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The micropuncture pedal access set by Cook received FDA clearance through the 510(k) pathway on May 3, 2018. It is classified as a Class 2 device under product code DYB.
What It Is
The micropuncture pedal access set is designed to facilitate vascular access in the lower extremities, particularly the pedal arteries. It typically includes a needle, guidewire, and introducer sheath, allowing for precise entry into small vessels. This device is particularly useful in procedures requiring access to the distal vasculature, such as in the treatment of peripheral artery disease.
FDA-Cleared Indications
- Facilitates percutaneous access to the pedal arteries.
- Provides vascular access for endovascular procedures, including embolization.
- Intended for use in the peripheral vasculature when access to small distal vessels is required.
Clinical Applications
- Obtaining percutaneous access to a pedal artery for an endovascular intervention.
- Providing distal lower-extremity access for embolization procedures when pedal arterial access is selected.
- Establishing access for diagnostic angiography or catheter-based treatment of the lower-extremity arterial system, when consistent with the device labeling and procedural plan.
Reported off-label uses
- Retrograde tibiopedal access for selected chronic limb-threatening ischemia interventions.
- Retrograde pedal access to support crossing or treatment of complex below-the-knee arterial occlusions.
- Distal access for selected peripheral angioplasty or atherectomy procedures.
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 set is intended for small-vessel access; the operator should select the needle, guidewire, and sheath configuration appropriate for the target pedal artery and planned procedure.
- Pedal arteries may be small, tortuous, or heavily calcified, making ultrasound or fluoroscopic guidance and careful wire handling important.
- Compatibility with subsequent guidewires, catheters, and other devices should be confirmed before use, including the required sheath or introducer diameter.
- MRI safety depends on the specific components and whether any device remains in the patient; consult the current Cook labeling and MRI conditions before scanning.
- Contraindications and precautions include unsuitable arterial anatomy, severe access-site disease, infection, bleeding risk, or inability to maintain safe distal perfusion. Use must follow the current instructions for use.
Related Literature
The study titled 'Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions' explores the use of tibiopedal access for treating occlusions in the arteries below the knee. While specific details and findings are not available, the study likely highlights the effectiveness and safety of using pedal access in complex vascular interventions. Limitations may include a small sample size or lack of long-term follow-up data.
Procedures that use this device
Frequently Asked Questions
What is the micropuncture pedal access set used for?
It is used for obtaining vascular access in the lower extremities, particularly for procedures like embolization and angioplasty.
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 facilitating access to the pedal arteries for vascular interventions, particularly in patients with peripheral artery disease.
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.