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introducer cat int-06fr
Sorensen Research
Summary: The introducer cat int-06fr is a device used in embolization procedures, primarily for vascular access. Key evidence includes studies on its application in veterinary and human models.
FDA Clearance Information
Pathway
510K
Number
K771041 ↗
Decision Date
July 13, 1977
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The introducer cat int-06fr was cleared by the FDA through the 510(k) pathway on July 13, 1977. It is manufactured by Sorensen Research and classified as a Class 2 device.
What It Is
The introducer cat int-06fr is a catheter designed for vascular access, facilitating the introduction of other devices into the vascular system. It is commonly used in embolization procedures.
Clinical Applications
This device is typically used in clinical scenarios requiring vascular access, such as embolization procedures. It provides a conduit for the insertion of embolization coils or other interventional tools.
Evidence Summary
The available literature includes 8 studies, encompassing various study types such as RCTs, prospective, and retrospective studies. The studies span from 2022 to 2025.
Reported Outcomes
Published studies report the introducer cat int-06fr is effective in facilitating vascular access in both veterinary and human models. Outcomes include successful embolization and improved procedural efficiency in complex cases.
Safety Profile
Reported complications include potential vascular injury and device-related infections. However, specific safety data from the provided studies is limited.
Evidence Limitations
The evidence is limited by a lack of large-scale human trials and detailed safety data. Further research is needed to establish comprehensive safety profiles and long-term outcomes.
Frequently Asked Questions
What are the clinical indications for introducer cat int-06fr?
The device is indicated for use in embolization procedures requiring vascular access.
What outcomes have been reported in clinical studies?
Studies report successful vascular access and procedural efficiency in embolization cases.
What complications have been reported?
Reported complications include potential vascular injury and device-related infections.
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.