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cardiac function laboratory pressure interface pressure volume catheter
Cd Leycom
Summary: The cardiac function laboratory pressure interface pressure volume catheter by Cd Leycom is a device used for assessing cardiac function. It was FDA cleared via 510k in 2001. Key evidence includes studies on cardiac hypertrophy and bioelectronics.
FDA Clearance Information
Pathway
510K
Number
K003020 ↗
Decision Date
May 11, 2001
Product Code
DQO
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA through the 510k pathway on May 11, 2001. It is manufactured by Cd Leycom and classified as a Class 2 device under product code DQO.
What It Is
This device is a catheter designed to interface with pressure volume systems in cardiac function laboratories. It is intended for the assessment of cardiac function by measuring pressure-volume relationships in the heart.
Clinical Applications
Commonly used in cardiac function laboratories, this device is applied in scenarios requiring detailed hemodynamic assessment, such as evaluating cardiac performance and diagnosing heart conditions.
Evidence Summary
The literature includes 15 studies, with a mix of RCTs, prospective, and retrospective designs. The studies span from 2024 to 2026, focusing on cardiac hypertrophy and bioelectronics.
Reported Outcomes
Published studies report advancements in understanding cardiac hypertrophy and the potential of piezo-electronics in bioelectronics. However, specific efficacy outcomes related to the catheter itself are not detailed in the provided evidence.
Safety Profile
Reported complications include general risks associated with catheterization, but specific adverse events related to this device are not detailed in the provided evidence.
Evidence Limitations
The evidence lacks specific outcomes directly related to the catheter's efficacy and safety. Further research is needed to establish detailed clinical outcomes and safety profiles.
Frequently Asked Questions
What are the clinical indications for cardiac function laboratory pressure interface pressure volume catheter?
The device is indicated for use in cardiac function laboratories to assess cardiac performance by measuring pressure-volume relationships.
What outcomes have been reported in clinical studies?
Studies have focused on cardiac hypertrophy and bioelectronics, but specific outcomes related to the catheter are not detailed.
What complications have been reported?
Reported complications include general risks of catheterization; specific adverse events for this device are not detailed.
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.