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enpath deflectable catheter
Enpath Medical
Summary: The Enpath Deflectable Catheter is a medical device used in procedures requiring venous access and manipulation, often employed by interventional cardiologists and radiologists. It is designed for precise navigation within the vascular system.
FDA Clearance Information
Pathway
510K
Number
K043489 ↗
Decision Date
May 19, 2005
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Enpath Deflectable Catheter was cleared through the FDA 510(k) pathway on May 19, 2005. Manufactured by Enpath Medical, it is classified as a Class 2 device under product code DQY.
What It Is
The Enpath Deflectable Catheter is a specialized catheter designed to navigate the venous system with precision. It features a deflectable tip, allowing clinicians to steer and position the catheter accurately within the vascular anatomy. This capability is crucial for accessing difficult-to-reach areas and performing interventions with minimal trauma to the vessel walls.
Clinical Applications
This catheter is commonly used in interventional cardiology and radiology for procedures such as venous stenting and electrophysiological studies. It is particularly useful in settings where precise catheter placement is necessary, such as in patients with complex vascular anatomies. The device is suitable for adult patients requiring venous interventions.
Indications for Use
The FDA indications suggest that this catheter is intended for use in procedures involving venous access and manipulation. It is particularly beneficial for patients requiring stenting or other interventions within the venous system.
Practical Considerations
The Enpath Deflectable Catheter is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with standard guidewires and introducer sheaths. Clinicians should be familiar with catheter manipulation techniques to maximize its efficacy and minimize potential complications.
Frequently Asked Questions
What is the Enpath Deflectable Catheter used for?
It is used for navigating and accessing the venous system during interventional procedures, such as venous stenting.
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 procedures requiring venous access and manipulation, such as stenting within the venous system.
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.