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cardiosolutions percu-pro steerable introducer
Cardiosolutions
Summary: The Cardiosolutions Percu-Pro Steerable Introducer is a medical device used to facilitate the introduction of catheters and other devices into the vascular system. It is primarily used by interventional cardiologists and radiologists in procedures requiring precise vascular access.
FDA Clearance Information
Pathway
510K
Number
K131332 ↗
Decision Date
July 19, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Cardiosolutions Percu-Pro Steerable Introducer was cleared through the FDA 510(k) pathway on July 19, 2013. Manufactured by Cardiosolutions, it is classified as a Class 2 medical device under product code DYB.
What It Is
The Cardiosolutions Percu-Pro Steerable Introducer is a specialized medical device designed to aid in the insertion of catheters and other devices into the vascular system. Its steerable design allows for precise navigation and placement, which is crucial in complex vascular procedures. This device enhances the clinician's ability to access difficult-to-reach areas within the vascular system, improving procedural outcomes.
Clinical Applications
This device is commonly used in interventional cardiology and radiology for procedures such as embolization, angioplasty, and other catheter-based interventions. It is particularly useful in settings where precise vascular access is required, such as in patients with challenging anatomy or in procedures involving the coronary or peripheral arteries. The device is suitable for use in hospitals and specialized cardiovascular centers.
Indications for Use
The FDA-cleared indications for the Cardiosolutions Percu-Pro Steerable Introducer include its use in facilitating the introduction of devices into the vascular system. It is intended for patients requiring vascular access for diagnostic or therapeutic procedures, particularly in cases where traditional introducers may not provide the necessary precision.
Practical Considerations
The device typically comes in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with a range of catheters and devices used in vascular interventions. Clinicians should be trained in the use of steerable introducers to maximize the benefits of its design, ensuring accurate placement and minimizing the risk of vascular injury.
Frequently Asked Questions
What is the Cardiosolutions Percu-Pro Steerable Introducer used for?
It is used to facilitate the introduction of catheters and other devices into the vascular system, particularly in procedures requiring precise access.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in procedures involving vascular access.
What are the FDA-cleared indications?
The device is indicated for facilitating the introduction of devices into the vascular system for diagnostic or therapeutic procedures.
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.