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enpath medical steerable sheath
Enpath Medical
Summary: The Enpath Medical Steerable Sheath is a medical device used in procedures involving venous stents. It is primarily utilized by interventional cardiologists and radiologists to navigate and deploy stents within the venous system.
FDA Clearance Information
Pathway
510K
Number
K061119 ↗
Decision Date
May 18, 2006
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Enpath Medical Steerable Sheath was cleared through the FDA 510k pathway on May 18, 2006. Manufactured by Enpath Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Enpath Medical Steerable Sheath is a specialized catheter designed to provide precise control and navigation within the venous system. It features a steerable tip that allows clinicians to maneuver through complex vascular pathways, facilitating the placement of stents. This device is particularly useful in procedures requiring high precision and control, such as those involving tortuous or challenging venous anatomy.
Clinical Applications
This device is commonly used in interventional cardiology and radiology settings, particularly in procedures involving the placement of venous stents. It is suitable for use in hospitals and specialized clinics where vascular interventions are performed. The steerable sheath is beneficial for patients with conditions such as venous obstructions or other vascular abnormalities that require stenting.
Indications for Use
The FDA-cleared indications for the Enpath Medical Steerable Sheath include its use in procedures requiring the placement of venous stents. It is intended for patients who need stent deployment within the venous system, often due to blockages or structural issues.
Practical Considerations
The Enpath Medical Steerable Sheath is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of stents and guidewires, making it versatile for various vascular interventions. Clinicians should be familiar with its steering mechanism to maximize its benefits during procedures.
Frequently Asked Questions
What is the Enpath Medical Steerable Sheath used for?
It is used for navigating and deploying venous stents within the vascular system, particularly in complex or challenging anatomies.
What specialties typically use this device?
Interventional cardiologists and radiologists commonly use this device in vascular procedures.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring the placement of venous stents, particularly in patients with venous obstructions or abnormalities.
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.