📋 FDA Reference
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 ?
510(k)
Number ?
K043489 ↗
Decision Date ?
May 19, 2005
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Percutaneous catheter access to and manipulation within the venous system.
- Use when controlled catheter steering and positioning are needed during a venous intervention.
Clinical Applications
- Selective access and catheter positioning within central or peripheral veins.
- Venous interventions in patients whose anatomy requires controlled catheter deflection.
- Catheter manipulation during procedures involving venous access.
Practical Considerations
- Available size, length, working-channel, and guidewire compatibility depend on the specific catalog configuration; confirm these details before use.
- The catheter is introduced through a percutaneous access site, commonly through an introducer sheath, under fluoroscopic or other appropriate imaging guidance.
- Operators should use controlled advancement and deflection to reduce the risk of vessel injury, dissection, perforation, thrombosis, or arrhythmia when working near the heart.
- MRI safety depends on the exact device model and labeling. Do not assume the catheter is MRI safe or MRI conditional without reviewing the current manufacturer instructions for use.
- Contraindications, warnings, and limitations should be taken from the current manufacturer labeling; general catheter risks include bleeding, infection, vascular injury, embolization, and contrast-related complications.
Procedures that use this device
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.