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introducer cat int-05fr
Sorensen Research
Summary: The introducer cat int-05fr is a device used primarily in embolization procedures. Key evidence highlights its application in veterinary and endovascular settings.
FDA Clearance Information
Pathway
510K
Number
K771042 ↗
Decision Date
July 13, 1977
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The introducer cat int-05fr was cleared by the FDA via 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-05fr is a catheter device designed for introducing other instruments or fluids into the body. It is commonly used in embolization procedures, particularly involving coils.
Clinical Applications
This device is often used in clinical scenarios requiring vascular access for embolization, such as in the treatment of aneurysms or arteriovenous malformations. It is also utilized in veterinary medicine for complex procedures.
Evidence Summary
The literature includes 8 studies ranging from 2022 to 2025, encompassing various study types such as RCTs and case series. These studies explore the device's application in both human and veterinary medicine.
Reported Outcomes
Published studies report the introducer cat int-05fr's efficacy in facilitating complex procedures like thrombus removal and balloon dilation. It has been shown to improve procedural success rates in both human and veterinary applications.
Safety Profile
Reported complications include procedural challenges related to device insertion and potential vascular injury. However, specific adverse events are not extensively detailed in the available literature.
Evidence Limitations
The evidence is limited by a lack of large-scale, randomized controlled trials specifically focusing on the device. Further research is needed to better understand long-term outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for introducer cat int-05fr?
The device is indicated for use in embolization procedures and other scenarios requiring vascular access, as per FDA documentation.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural success rates in both human and veterinary applications, particularly in complex vascular procedures.
What complications have been reported?
Safety data indicate potential complications such as procedural challenges and vascular injury, though detailed adverse events are not extensively documented.
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.