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introducer set
Advanced Cardiovascular Systems
Summary: The introducer set by Advanced Cardiovascular Systems is a medical device used primarily for vascular access and embolization procedures. Key evidence highlights its use in complex embolization cases.
FDA Clearance Information
Pathway
510K
Number
K821188 ↗
Decision Date
July 8, 1982
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The introducer set was cleared by the FDA through the 510(k) pathway on July 8, 1982. It is manufactured by Advanced Cardiovascular Systems and classified as a Class 2 device.
What It Is
The introducer set is a medical device designed for facilitating vascular access, often used in procedures requiring the insertion of catheters or other devices into blood vessels. It is intended for use in embolization and other interventional radiology procedures.
Clinical Applications
Common clinical scenarios for the introducer set include embolization procedures, particularly in cases involving complex vascular anatomy or challenging access points. It is also used in sialoendoscopy and percutaneous catheter placements.
Evidence Summary
The available literature includes 15 studies, comprising various study types such as RCTs, prospective, and retrospective studies. The research spans from 2007 to 2024, highlighting the device's application in diverse clinical settings.
Reported Outcomes
Published studies report successful embolization in challenging cases, such as type 2 endoleaks, using the introducer set. The device has also been associated with improved procedural success rates in sialoendoscopy and PICC placements.
Safety Profile
Reported complications include potential malposition during catheter placement, which can lead to procedural delays and increased radiation exposure due to repeated imaging. However, advancements in technology have mitigated some of these risks.
Evidence Limitations
The evidence is limited by a lack of large-scale randomized controlled trials specifically focused on the introducer set. Further research is needed to explore long-term outcomes and comparative effectiveness against alternative devices.
Frequently Asked Questions
What are the clinical indications for the introducer set?
The introducer set is indicated for use in vascular access procedures, including embolization and catheter placements, as detailed in FDA documentation.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful outcomes in embolization procedures and improved success rates in sialoendoscopy and PICC placements.
What complications have been reported?
Safety data from evidence indicate complications such as catheter malposition and procedural delays, although technological advancements have reduced these risks.
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.