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Venture 0 014 Catheter
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 ?
510(k)
Number ?
K182570 ↗
Decision Date ?
March 13, 2019
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Use in percutaneous vascular interventions involving stenotic or tortuous vessels.
- Use in both arterial and venous vascular anatomy.
- Use with 0.014-inch guidewires to support navigation and guidewire direction.
Clinical Applications
- Crossing selected stenotic arterial or venous segments during percutaneous vascular intervention.
- Navigating tortuous arterial or venous anatomy when additional catheter steerability and guidewire support are needed.
- Directing a 0.014-inch guidewire toward a difficult-to-reach vascular branch or segment.
- Use in selected adult and pediatric vascular interventions, when the device is appropriate for the patient and procedure.
Practical Considerations
- The catheter is designed for compatibility with 0.014-inch guidewires; confirm compatibility with the guidewire, introducer, sheath and other procedural equipment before use.
- The radiopaque distal tip can be manually angulated up to approximately 90 degrees. Operators should understand the steering mechanism and avoid excessive force or manipulation.
- Use fluoroscopic or other appropriate intravascular imaging guidance according to the procedure. The device is intended for trained clinicians familiar with percutaneous vascular intervention.
- The available size, working length and configuration should be verified in the current manufacturer instructions for use, because specifications may vary by model.
- MRI safety should be confirmed from the current device labeling and institutional policy before scanning; this record does not establish that the catheter is MR Safe or MR Conditional.
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.
Procedures that use this device
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.