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introducer cat int-07fr
Sorensen Research
Summary: The introducer cat int-07fr by Sorensen Research is a device used primarily for embolization-coil procedures. Key evidence includes studies on its application in veterinary and human models.
FDA Clearance Information
Pathway
510K
Number
K771040 ↗
Decision Date
June 29, 1977
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The introducer cat int-07fr was cleared by the FDA via the 510(k) pathway on June 29, 1977. It is manufactured by Sorensen Research and classified as a Class 2 device.
What It Is
The introducer cat int-07fr is a catheter device designed for facilitating the placement of embolization coils. It is used in interventional procedures to access vascular structures.
Clinical Applications
Commonly used in embolization procedures, the introducer cat int-07fr is employed in both human and veterinary medicine to aid in the delivery of therapeutic agents or devices to targeted sites.
Evidence Summary
The literature includes 8 studies ranging from 2022 to 2025, covering various applications of the device. Study types include RCTs, prospective, and retrospective analyses.
Reported Outcomes
Published studies report the introducer cat int-07fr as effective in facilitating procedures such as transapical balloon dilation and thrombus removal. Outcomes include improved procedural success and training efficacy.
Safety Profile
Reported complications include procedural challenges in complex anatomical scenarios. However, specific adverse events were not detailed in the available studies.
Evidence Limitations
The evidence is limited by a lack of large-scale human trials and detailed safety data. Further research is needed to fully understand the device's efficacy and safety profile in diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for introducer cat int-07fr?
The device is indicated for use in embolization-coil procedures, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies report successful facilitation of procedures like thrombus removal and balloon dilation, with improved training outcomes.
What complications have been reported?
Reported complications include procedural challenges, but specific adverse events were not detailed in the 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.