đź“‹ FDA Reference
ilt deflecting catheter model c114nd1
Intra Luminal Therapeutics
Summary: The ILT Deflecting Catheter Model C114ND1 is a steerable catheter used in interventional radiology and neurovascular procedures. It is designed for navigating complex vascular anatomy and is primarily used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K010531 ↗
Decision Date
April 18, 2001
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The ILT Deflecting Catheter Model C114ND1 was cleared by the FDA through the 510(k) pathway on April 18, 2001. Manufactured by Intra Luminal Therapeutics, it is classified as a Class 2 device under product code DQY.
What It Is
The ILT Deflecting Catheter Model C114ND1 is a steerable catheter designed to facilitate access and navigation through complex vascular pathways, particularly in the venous system. Its deflecting tip allows for precise maneuverability, making it ideal for reaching difficult-to-access areas. This device is particularly useful in procedures requiring the placement of stents or other therapeutic devices in tortuous or branching vessels.
Clinical Applications
This catheter is commonly used in interventional radiology and neurovascular procedures, where precise navigation through the vascular system is critical. It is particularly beneficial in treating conditions involving the venous system, such as placing stents in narrowed or blocked veins. The device is used in hospital settings, primarily by interventional radiologists and neurosurgeons, to treat patients with complex vascular conditions.
Indications for Use
The FDA indications suggest that this device is intended for use in procedures requiring navigation through the venous system, particularly in cases where access to complex or tortuous anatomy is necessary. It is suitable for patients needing stent placement or other interventions in challenging vascular regions.
Practical Considerations
The ILT Deflecting Catheter is typically available in various sizes to accommodate different patient anatomies and procedural needs. It is compatible with standard interventional radiology equipment and requires careful handling to optimize its steerability and effectiveness. Clinicians should be familiar with catheter navigation techniques to maximize the device's utility.
Related Literature
The linked study evaluated the use of the 2.0 Fr SwiftNINJA microcatheter, a similar steerable device, in navigating complex neurovascular anatomy. The study demonstrated the catheter's effectiveness in accessing small-caliber cerebral vessels and delivering therapeutic devices, highlighting its utility in challenging vascular cases. However, the study's focus on a specific microcatheter and limited patient population may restrict the generalizability of its findings.
Frequently Asked Questions
What is the ILT Deflecting Catheter Model C114ND1 used for?
It is used for navigating complex vascular anatomy, particularly in the venous system, to facilitate procedures like stent placement.
What specialties typically use this device?
Interventional radiologists and neurosurgeons typically use this device in hospital settings.
What are the FDA-cleared indications?
The device is indicated for use in procedures requiring navigation through the venous system, especially in complex or tortuous anatomy.
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.