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transseptal introducer set
Thomas Medical Products
Summary: The transseptal introducer set by Thomas Medical Products is used for transseptal left heart catheterization. Key evidence highlights its safety and versatility in pediatric and adult patients.
FDA Clearance Information
Pathway
510K
Number
K932619 ↗
Decision Date
August 24, 1993
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The transseptal introducer set was cleared by the FDA via the 510(k) pathway on August 24, 1993. It is manufactured by Thomas Medical Products and classified as a Class 2 device.
What It Is
The transseptal introducer set is a medical device designed to facilitate transseptal left heart catheterization. It is used to access the left atrium through the septum, primarily in cardiac procedures.
Clinical Applications
This device is commonly used in procedures requiring access to the left heart, such as in patients with complex cardiac conditions. It is particularly useful in both pediatric and adult populations.
Evidence Summary
The available literature includes a study from 1984 involving 520 patients, highlighting the device's safety and efficacy. The studies range from retrospective to prospective designs.
Reported Outcomes
Published studies report that the transseptal introducer set is a safe and effective tool for left heart catheterization. It has been successfully used in a wide age range, from infants to adults, demonstrating its versatility.
Safety Profile
Reported complications include minimal adverse events, emphasizing the device's safety profile. The studies highlight its dependability in clinical use without significant complications.
Evidence Limitations
The evidence is limited by the age of the studies and the lack of recent large-scale trials. Further research is needed to confirm long-term safety and efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for transseptal introducer set?
The device is indicated for transseptal left heart catheterization, particularly in patients requiring access to the left atrium.
What outcomes have been reported in clinical studies?
Studies report successful catheterization with a high safety profile across a range of patient ages.
What complications have been reported?
Safety data indicate minimal complications, with studies emphasizing the device's reliable safety profile.
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.