đź“Š Evidence-Based Reference
percutaneous catheter introducer w cath-seal sid
Universal Medical Instrument
Summary: The percutaneous catheter introducer with cath-seal sid by Universal Medical Instrument is a device used for vascular access. It is primarily used in procedures requiring embolization coils. Key evidence highlights its technical feasibility and safety.
FDA Clearance Information
Pathway
510K
Number
K850820 ↗
Decision Date
April 10, 1985
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on April 10, 1985. It is manufactured by Universal Medical Instrument and is classified as a Class 2 device under product code DYB.
What It Is
The percutaneous catheter introducer with cath-seal sid is designed to facilitate vascular access for the introduction of embolization coils. It is used in interventional radiology and other procedures requiring precise catheter placement.
Clinical Applications
This device is commonly used in clinical scenarios involving embolization procedures, such as in the treatment of vascular abnormalities or tumors. It provides a reliable means of accessing the vascular system for therapeutic interventions.
Evidence Summary
The available literature includes a range of study types, such as RCTs, case series, and feasibility studies, with a total of 5 studies reviewed. The studies span from 2008 to 2024, providing insights into the device's application and safety.
Reported Outcomes
Published studies report successful use of the device in various procedures, including hepatic arterial infusion and osteoid osteoma ablation. Outcomes include high symptom-free rates and primary success rates in specific applications, with minimal recurrence observed.
Safety Profile
Reported complications include no significant adverse events in the reviewed studies, indicating a favorable safety profile. The device's use in a downsized coaxial catheter system showed no pericatheter bleeding, highlighting its safety in clinical practice.
Evidence Limitations
The evidence is limited by the small sample sizes and the focus on specific applications. Further research is needed to explore broader clinical applications and long-term outcomes. Some studies are retrospective, which may introduce bias.
Frequently Asked Questions
What are the clinical indications for percutaneous catheter introducer w cath-seal sid?
The device is indicated for use in procedures requiring vascular access for embolization coils, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Studies report high symptom-free and primary success rates in specific applications, with minimal recurrence and no significant complications.
What complications have been reported?
Safety data from evidence indicate no significant adverse events, with studies showing a favorable safety profile in clinical use.
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.