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micropuncture introducer sets micropuncture pedal access sets
Cook, Medical
Summary: The micropuncture introducer sets by Cook Medical are used for vascular access, particularly in small or difficult-to-access vessels. They are primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K240589 ↗
Decision Date
March 25, 2024
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The micropuncture introducer sets by Cook Medical were cleared through the FDA 510(k) pathway on March 25, 2024. This Class 2 device is identified under product code DYB.
What It Is
The micropuncture introducer sets are medical devices designed to facilitate access to small or challenging blood vessels. They typically include a needle, guidewire, and sheath/dilator assembly. These sets are used to establish initial vascular access, often as a precursor to larger catheter placements or interventions.
Clinical Applications
These devices are commonly used in interventional radiology and vascular surgery settings. They are essential in procedures requiring precise access to small vessels, such as in peripheral artery disease interventions or embolization procedures. The micropuncture technique is particularly beneficial in patients with challenging vascular anatomy or compromised vessel integrity.
Indications for Use
The FDA indications suggest these sets are intended for use in gaining vascular access in patients requiring interventions like embolization. They are suitable for patients with conditions that necessitate precise vascular entry, such as those undergoing treatment for vascular occlusions or aneurysms.
Practical Considerations
Clinicians should consider the typical sizing of these sets, which often include small gauge needles and compatible guidewires. Proper technique is crucial to avoid vessel trauma, and compatibility with other vascular devices should be confirmed prior to use.
Frequently Asked Questions
What is micropuncture introducer sets used for?
They are used for gaining vascular access in small or difficult-to-access vessels, often as a precursor to larger interventions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons commonly use these devices.
What are the FDA-cleared indications?
They are indicated for vascular access in procedures requiring precise entry into small vessels, such as embolization or catheterization.
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.