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sheath adapter model sa-09847
Arrow Intl.
Summary: The sheath adapter model SA-09847 by Arrow Intl. is used in embolization-coils procedures. Key evidence includes studies on insertion force and microglial expansion.
FDA Clearance Information
Pathway
510K
Number
K021723 ↗
Decision Date
August 8, 2002
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The sheath adapter model SA-09847 was cleared by the FDA through the 510(k) pathway on August 8, 2002. It is manufactured by Arrow Intl. and classified as a Class 2 device.
What It Is
The sheath adapter model SA-09847 is designed for use in embolization-coils procedures. It facilitates the insertion and positioning of medical devices within the vascular system, enhancing procedural efficiency.
Clinical Applications
This device is commonly used in interventional radiology and vascular surgery for procedures involving embolization coils. It aids in the precise delivery of coils to target sites within the vasculature.
Evidence Summary
The literature includes four studies, ranging from 2002 to 2025, with various study designs such as RCTs and prospective analyses. These studies explore insertion force and cellular responses.
Reported Outcomes
Published studies report on the peak force of insertion during ureteral access sheath placement, highlighting variations among different commercially available sheaths. Other studies focus on cellular mechanisms in response to device use.
Safety Profile
Reported complications include potential resistance during insertion, which may affect procedural success. No specific adverse events related to the sheath adapter were detailed in the provided studies.
Evidence Limitations
The evidence is limited by the diversity of study designs and the focus on specific cellular mechanisms rather than direct clinical outcomes. Further research is needed to establish comprehensive safety and efficacy profiles.
Frequently Asked Questions
What are the clinical indications for sheath adapter model SA-09847?
The sheath adapter is indicated for use in embolization-coils procedures, facilitating the delivery and positioning of devices within the vascular system.
What outcomes have been reported in clinical studies?
Studies have reported on the peak force of insertion and cellular responses, providing insights into procedural efficiency and device interaction with biological tissues.
What complications have been reported?
Safety data indicate potential resistance during insertion, but no specific adverse events related to the sheath adapter were 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.