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plato 17 microcatheter
Scientia Vascular
Summary: The plato 17 microcatheter is a device used in endovascular procedures to navigate and deliver therapeutic agents within the vascular system. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway 510K
Number K210601 ↗
Decision Date April 28, 2021
Product Code DQY
Device Class Class 2
Evidence 0 studies
The plato 17 microcatheter by Scientia Vascular was cleared through the FDA 510(k) pathway on April 28, 2021. It is classified as a Class 2 device under product code DQY.
What It Is
The plato 17 microcatheter is a small, flexible catheter designed for use in minimally invasive endovascular procedures. It allows for precise navigation through the vascular system to deliver therapeutic agents or devices. Its design facilitates access to small and tortuous vessels, making it a valuable tool in complex vascular interventions.
Clinical Applications
This microcatheter is commonly used in procedures such as embolization, where it helps deliver embolic agents to block blood flow to specific areas, such as tumors or arteriovenous malformations. It is also used in the placement of venous stents and other vascular interventions. The device is typically utilized in hospital settings by interventional radiologists and vascular surgeons, often in patients with vascular abnormalities or conditions requiring precise vascular access.
Indications for Use
The FDA indications for the plato 17 microcatheter include its use in endovascular procedures requiring the delivery of therapeutic agents or devices within the vascular system. It is suitable for patients needing interventions in small or difficult-to-access vessels.
Practical Considerations
The plato 17 microcatheter is available in various sizes to accommodate different vessel diameters and procedural needs. It is compatible with standard guidewires and embolic materials. Clinicians should be familiar with catheter navigation techniques to optimize its use in complex vascular anatomies.
Frequently Asked Questions
What is the plato 17 microcatheter used for?
The plato 17 microcatheter is used for navigating and delivering therapeutic agents or devices within the vascular system during endovascular procedures.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the plato 17 microcatheter in their procedures.
What are the FDA-cleared indications?
The FDA-cleared indications include use in endovascular procedures for delivering therapeutic agents or devices in the vascular system, particularly in small or difficult-to-access vessels.
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.