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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 ?
510(k)
Number ?
K061119 ↗
Decision Date ?
May 18, 2006
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Used as a percutaneous catheter during procedures involving the placement of venous stents.
- Provides access and steerable catheter control within the vascular system for the intended intervention.
Clinical Applications
- Accessing the venous system during venous stent placement.
- Navigating through difficult or curved venous anatomy to support delivery of a venous stent.
- Providing a working channel for compatible guidewires, catheters, or stent-delivery systems during a labeled venous intervention.
Practical Considerations
- Available sizes and working-channel dimensions depend on the specific Enpath Medical model and should be confirmed in the device labeling.
- Compatibility with guidewires, catheters, and venous stent-delivery systems must be checked before use.
- The operator should be trained to control the steerable tip and should use fluoroscopic or other appropriate imaging guidance.
- Contraindications, access-site limitations, anticoagulation requirements, and handling instructions are specified in the product labeling.
- MRI safety should not be assumed; confirm the exact model's MR Safe, MR Conditional, or MR Unsafe status in the current labeling.
Procedures that use this device
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.