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cath-seal
Universal Medical Instrument
Summary: Cath-seal is a vascular closure device used primarily for embolization procedures. It is FDA 510k cleared and linked to five studies, though specific outcomes and safety data are not detailed in the provided evidence.
FDA Clearance Information
Pathway
510K
Number
K935077 ↗
Decision Date
June 7, 1994
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
Cath-seal was cleared by the FDA through the 510k pathway on June 7, 1994. It is manufactured by Universal Medical Instrument and classified as a Class 2 device.
What It Is
Cath-seal is a medical device designed to facilitate vascular closure following procedures such as embolization. It operates by sealing the puncture site to prevent bleeding and promote healing.
Clinical Applications
Cath-seal is commonly used in interventional radiology and cardiology for procedures requiring vascular access, such as embolization-coils placement, to achieve rapid hemostasis and reduce complications associated with manual compression.
Evidence Summary
The available literature includes five studies, primarily observational, focusing on various aspects of vascular closure and related procedures. However, specific details on outcomes and safety are not provided in the evidence summary.
Reported Outcomes
Published studies report limited specific outcomes related to cath-seal. The evidence provided does not detail efficacy findings, highlighting a gap in comprehensive outcome data.
Safety Profile
Reported complications include general concerns associated with vascular closure devices, but specific adverse events related to cath-seal are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks detailed outcome and safety data specific to cath-seal, indicating a need for further research to establish comprehensive efficacy and safety profiles. Study limitations include a lack of randomized controlled trials and specific patient population data.
Frequently Asked Questions
What are the clinical indications for cath-seal?
Cath-seal is indicated for use in vascular closure following procedures such as embolization-coils placement.
What outcomes have been reported in clinical studies?
The evidence provided does not detail specific outcomes for cath-seal, indicating a gap in the literature.
What complications have been reported?
Safety data specific to cath-seal is not detailed in the provided evidence, highlighting a need for further research.
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.