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catheter introducer kit
Electro-Catheter
Summary: The catheter introducer kit by Electro-Catheter is a medical device used primarily for the introduction of catheters into the vascular system. Key evidence highlights potential complications such as air embolism.
FDA Clearance Information
Pathway
510K
Number
K770427 ↗
Decision Date
March 16, 1977
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The catheter introducer kit was cleared by the FDA via the 510k pathway on March 16, 1977. It is manufactured by Electro-Catheter and classified as a Class 2 device.
What It Is
The catheter introducer kit is designed to facilitate the insertion of catheters into the vascular system. It is commonly used in procedures requiring vascular access, such as the placement of pulmonary artery catheters.
Clinical Applications
This device is frequently used in clinical settings for procedures that require reliable vascular access. It is particularly useful in critical care and interventional cardiology for the introduction of various types of catheters.
Evidence Summary
The available literature includes two studies from 1982, both focusing on the safety of the catheter introducer kit. These studies highlight the occurrence of air embolism as a potential complication.
Reported Outcomes
Published studies report that the primary concern associated with the catheter introducer kit is the risk of air embolism. No specific efficacy outcomes were detailed in the available studies.
Safety Profile
Reported complications include the occurrence of air embolism associated with the use of the catheter introducer kit. Both studies from 1982 highlight this safety concern.
Evidence Limitations
The evidence is limited to two studies from 1982, both of which focus on safety rather than efficacy. Further research is needed to evaluate the device's performance and safety in contemporary clinical settings.
Frequently Asked Questions
What are the clinical indications for catheter introducer kit?
The catheter introducer kit is indicated for use in procedures requiring vascular access, such as the introduction of pulmonary artery catheters.
What outcomes have been reported in clinical studies?
The studies primarily report on safety concerns, specifically the risk of air embolism associated with the device.
What complications have been reported?
Safety data from the evidence indicate that air embolism is a reported complication associated with the use of the catheter introducer kit.
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.