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peel-away introducer set
Quinton
Summary: The peel-away introducer set by Quinton is a medical device used for catheter placement. Key evidence highlights its utility in minimally invasive procedures.
FDA Clearance Information
Pathway
510K
Number
K844693 ↗
Decision Date
March 6, 1985
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The peel-away introducer set was cleared by the FDA via the 510(k) pathway on March 6, 1985. It is manufactured by Quinton and classified as a Class 2 device.
What It Is
The peel-away introducer set is designed to facilitate the insertion of catheters into the body. It allows for the safe and efficient placement of catheters by providing a sheath that can be peeled away once the catheter is in place.
Clinical Applications
Commonly used in procedures requiring catheter placement, the peel-away introducer set is utilized in scenarios such as central venous access and ureteral interventions. It is particularly useful in reducing trauma during catheter insertion.
Evidence Summary
The available literature includes four studies ranging from 1987 to 2013, covering various applications of the peel-away introducer set. These studies include case series and other observational designs.
Reported Outcomes
Published studies report the peel-away introducer set as effective in facilitating catheter placement with minimal trauma. It has been shown to be useful in both antegrade and retrograde procedures, enhancing procedural efficiency.
Safety Profile
Reported complications include minimal trauma during insertion and potential for dislodgement of stents. Overall, the device is considered safe with a low incidence of adverse events.
Evidence Limitations
The evidence is limited by the small number of studies and lack of randomized controlled trials. Further research is needed to explore long-term outcomes and compare efficacy with alternative devices.
Frequently Asked Questions
What are the clinical indications for peel-away introducer set?
The device is indicated for catheter placement in procedures such as central venous access and ureteral interventions.
What outcomes have been reported in clinical studies?
Studies report effective catheter placement with minimal trauma and enhanced procedural efficiency.
What complications have been reported?
Safety data indicate minimal trauma during insertion and potential for stent dislodgement as complications.
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.