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catheter introducer modification
Daig
Summary: The catheter introducer modification by Daig is a device used primarily for embolization procedures. Key evidence highlights its role in facilitating safe and effective catheter placement.
FDA Clearance Information
Pathway
510K
Number
K934285 ↗
Decision Date
November 24, 1993
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The catheter introducer modification was cleared by the FDA via the 510(k) pathway on November 24, 1993. It is manufactured by Daig and classified as a Class 2 device.
What It Is
The catheter introducer modification is a medical device designed to assist in the insertion of catheters into the vascular system. It is used to facilitate the placement of embolization coils and other interventional devices.
Clinical Applications
Commonly used in interventional radiology, the device aids in procedures requiring precise catheter placement, such as embolization to control bleeding or occlude blood vessels.
Evidence Summary
The literature includes 15 studies, encompassing a range of study types such as RCTs and case series, published between 2020 and 2024. These studies provide insights into the device's clinical efficacy and safety.
Reported Outcomes
Published studies report that the catheter introducer modification is effective in facilitating catheter placement with minimal trauma. In a study on brain lesion biopsy, histopathological diagnosis was successfully established in all cases without permanent deficits or major adverse outcomes.
Safety Profile
Reported complications include reduced invasiveness associated with brain biopsy procedures. No major adverse outcomes or permanent deficits were observed in the studies reviewed.
Evidence Limitations
The evidence is limited by the small sample sizes and the specific clinical contexts studied. Further research is needed to explore the device's efficacy across a broader range of clinical scenarios.
Frequently Asked Questions
What are the clinical indications for catheter introducer modification?
The device is indicated for use in embolization procedures and other interventions requiring precise catheter placement.
What outcomes have been reported in clinical studies?
Studies have reported successful catheter placement with minimal trauma and no major adverse outcomes.
What complications have been reported?
Safety data indicate reduced invasiveness and no major adverse outcomes or permanent deficits in the reviewed 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.