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micropuncture pedal access set
Cook
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
510K
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.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery settings for procedures like embolization and angioplasty. It is particularly beneficial in patients with peripheral artery disease where access to the tibiopedal arteries is necessary. The device is used in both hospital and outpatient settings, often in patients with complex vascular conditions requiring minimally invasive interventions.
Indications for Use
The FDA indications for this device include facilitating access to the pedal arteries for procedures such as embolization. It is intended for patients requiring vascular interventions in the lower extremities, often due to conditions like peripheral artery disease.
Practical Considerations
The micropuncture pedal access set typically comes in various sizes to accommodate different vessel diameters. It is compatible with standard guidewires and catheters used in vascular procedures. Clinicians should be aware of the technique required for accessing small and potentially calcified vessels in the foot.
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.
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.