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safe cross angled support 0 14 safe cross straight support catheter 0 14 safe cross angled support catheter safe crot
Intra Luminal Therapeutics
Summary: The Safe Cross Angled Support Catheter is a device used in venous stenting procedures. It is primarily utilized to provide support during catheterization. Key evidence includes FDA clearance and linked studies, though specific outcomes and safety data are not detailed.
FDA Clearance Information
Pathway
510K
Number
K030984 ↗
Decision Date
April 24, 2003
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The Safe Cross Angled Support Catheter was cleared by the FDA through the 510(k) pathway on April 24, 2003. It is manufactured by Intra Luminal Therapeutics and classified as a Class 2 device under product code DQY.
What It Is
The Safe Cross Angled Support Catheter is a medical device designed to assist in venous stenting procedures. It provides structural support during catheterization, facilitating the placement and stability of stents within venous structures.
Clinical Applications
This device is commonly used in clinical scenarios involving venous stenting, where support is needed to ensure proper catheter placement and stent deployment. It is particularly useful in complex vascular procedures requiring precise navigation and stability.
Evidence Summary
The available literature includes three studies linked to the device, though they primarily focus on unrelated topics such as multiple sclerosis. The studies do not provide direct evidence on the device's efficacy or safety.
Reported Outcomes
Published studies report no specific efficacy findings related to the Safe Cross Angled Support Catheter, as the linked studies focus on different clinical conditions and interventions.
Safety Profile
Reported complications include no specific safety data related to the Safe Cross Angled Support Catheter, as the linked studies do not address this device directly.
Evidence Limitations
The current evidence lacks direct studies on the Safe Cross Angled Support Catheter, highlighting a gap in specific efficacy and safety data. Further research is needed to evaluate its clinical outcomes and potential complications.
Frequently Asked Questions
What are the clinical indications for Safe Cross Angled Support Catheter?
The device is indicated for use in venous stenting procedures to provide support during catheterization.
What outcomes have been reported in clinical studies?
No specific outcomes related to the device have been reported in the linked studies.
What complications have been reported?
No specific complications related to the device have been reported in the linked studies.
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.