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umi cath-seal 13 14f transseptal catheter intro
Universal Medical Instrument
Summary: The umi cath-seal 13 14f transseptal catheter intro is a medical device used primarily in cardiac procedures to facilitate access to the left atrium. It is commonly used by cardiologists and interventional radiologists.
FDA Clearance Information
Pathway
510K
Number
K861984 ↗
Decision Date
August 5, 1986
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA's 510(k) pathway on August 5, 1986. It is manufactured by Universal Medical Instrument and classified as a Class 2 device under product code DYB.
What It Is
The umi cath-seal 13 14f transseptal catheter intro is a specialized catheter designed for transseptal access, allowing clinicians to reach the left atrium of the heart. This device is essential in procedures where direct access to the left side of the heart is required, such as in certain types of cardiac ablations or mitral valve interventions. Its design facilitates safe and effective passage through the septum, minimizing risks associated with transseptal punctures.
Clinical Applications
This catheter is commonly used in electrophysiology labs and cardiac catheterization suites. It is particularly useful in procedures such as atrial fibrillation ablation, where precise access to the left atrium is necessary. Cardiologists and interventional radiologists are the primary users, often working in hospital settings with patients who have complex cardiac conditions.
Indications for Use
The device is indicated for use in patients requiring transseptal access to the left atrium, typically during electrophysiological studies or interventions. It is suitable for conditions where direct cardiac access is necessary for therapeutic or diagnostic purposes.
Practical Considerations
The umi cath-seal 13 14f is available in sizes 13 and 14 French, making it compatible with standard introducer sheaths. Clinicians should be familiar with transseptal puncture techniques and ensure proper imaging guidance during procedures to optimize outcomes and minimize complications.
Frequently Asked Questions
What is umi cath-seal 13 14f transseptal catheter intro used for?
It is used for gaining transseptal access to the left atrium during cardiac procedures.
What specialties typically use this device?
Cardiologists and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for transseptal access to the left atrium for diagnostic or therapeutic cardiac procedures.
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.