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venture 0 014 catheter
Vascular Solutions
Summary: The Venture 0 014 Catheter is a steerable catheter used in complex vascular procedures, particularly in challenging anatomical scenarios. It is primarily used by interventional cardiologists and radiologists.
FDA Clearance Information
Pathway
510K
Number
K182570 ↗
Decision Date
March 13, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Venture 0 014 Catheter was cleared through the FDA 510(k) pathway on March 13, 2019. It is manufactured by Vascular Solutions and classified as a Class 2 device.
What It Is
The Venture 0 014 Catheter is a specialized catheter designed for navigating complex vascular anatomy. It features a steerable, tapered, radiopaque tip that can be manually angulated up to 90 degrees, allowing precise guidewire direction and support. This makes it particularly useful in navigating tortuous vessels and accessing difficult-to-reach areas.
Clinical Applications
This catheter is commonly used in interventional cardiology and radiology for procedures involving complex vascular anatomy, such as crossing stenotic or tortuous vessels. It is particularly useful in patients with congenital heart disease or those who have undergone previous surgical repairs. The device is suitable for both adult and pediatric populations.
Indications for Use
The FDA indications suggest that the Venture 0 014 Catheter is intended for use in vascular interventions where navigation through challenging anatomy is required. This includes crossing stenotic or tortuous vessels in both arteries and veins.
Practical Considerations
The catheter is compatible with 0.014-inch guidewires and features a steerable tip for precise navigation. Clinicians should be familiar with the manual angulation mechanism and ensure compatibility with other procedural tools. Proper technique is essential to maximize the device's utility.
Related Literature
The linked study explored the use of a wire control catheter in treating complex pulmonary artery or vein anatomy, highlighting its utility in congenital heart disease interventions. The study found that the catheter's steerable tip provided significant advantages in navigating challenging vascular structures. However, the study's limitations include its focus on a specific patient population and lack of broader clinical data.
Frequently Asked Questions
What is the Venture 0 014 Catheter used for?
It is used for navigating complex vascular anatomy, particularly in challenging scenarios such as tortuous or stenotic vessels.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device.
What are the FDA-cleared indications?
The catheter is indicated for use in vascular interventions requiring navigation through complex anatomy, such as stenotic or tortuous 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.