đź“‹ FDA Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Percutaneous introduction of catheters and other intravascular devices into the vascular system.
- Vascular access when a small-gauge needle and guidewire are used to establish initial access.
- Use during endovascular diagnostic and therapeutic procedures, including procedures requiring access for embolization.
Clinical Applications
- Obtaining initial arterial or venous access for angiography and endovascular intervention.
- Establishing access before placement of larger vascular sheaths, catheters, or guidewires.
- Providing access for embolization procedures when precise entry into a blood vessel is required.
- Accessing small, superficial, or technically challenging vessels when a standard access set may be less suitable.
Practical Considerations
- Set configurations vary and may include different needle gauges, guidewire diameters and lengths, sheath sizes, and sheath lengths; confirm the exact product specifications before use.
- Verify compatibility among the guidewire, dilator, introducer sheath, catheter, and any subsequently placed device.
- Use real-time ultrasound, fluoroscopy, or other appropriate imaging guidance according to the vessel and procedure. Careful wire and needle handling helps reduce dissection, perforation, bleeding, and other access-site injury.
- Review the individual product labeling for contraindications, warnings, storage requirements, and whether any component has specific MRI conditions. Do not assume the complete set is MRI safe based only on its metal components.
- Patient-specific factors such as severe peripheral vascular disease, coagulopathy, infection at the access site, or inability to tolerate the planned procedure may affect access-site selection and suitability.
Procedures that use this device
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.