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biflex tm temporary pacing probe
Advanced Medical Concepts
Summary: The Biflex TM Temporary Pacing Probe is a medical device used for temporary cardiac pacing. It is primarily used by cardiologists and cardiac surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K790983 ↗
Decision Date
July 10, 1979
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Biflex TM Temporary Pacing Probe was cleared through the FDA 510(k) pathway on July 10, 1979. It is manufactured by Advanced Medical Concepts and classified as a Class III device.
What It Is
The Biflex TM Temporary Pacing Probe is a device designed to provide temporary cardiac pacing for patients with arrhythmias or heart block. It consists of electrodes that deliver electrical impulses to stimulate the heart. This device is crucial in maintaining cardiac rhythm in acute settings, especially during or after cardiac surgery.
Clinical Applications
This device is commonly used in cardiology and cardiac surgery departments, particularly in intensive care units and operating rooms. It is essential for patients who require temporary pacing due to bradycardia or heart block, often following cardiac surgery or myocardial infarction. The probe is also used during electrophysiological studies and procedures.
Indications for Use
The Biflex TM Temporary Pacing Probe is indicated for patients who need temporary cardiac pacing support. This includes individuals with transient heart block or those recovering from cardiac surgery who exhibit bradyarrhythmias.
Practical Considerations
The probe is typically available in various lengths and configurations to accommodate different patient anatomies and clinical scenarios. It is compatible with standard pacing generators. Clinicians should ensure proper placement and secure fixation to prevent dislodgement during use.
Frequently Asked Questions
What is the Biflex TM Temporary Pacing Probe used for?
It is used for temporary cardiac pacing in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiology and cardiac surgery specialties commonly use this device.
What are the FDA-cleared indications?
The device is indicated for temporary pacing in patients with heart block or bradyarrhythmias, often post-surgery.
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.