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intermedics 430-07 bipol implant endocard pac lead
Intermedics
Summary: The Intermedics 430-07 Bipol Implant Endocard Pac Lead is a cardiac pacing lead used in patients requiring heart rhythm management. It is primarily used by cardiologists and electrophysiologists.
FDA Clearance Information
Pathway
510K
Number
K902672 ↗
Decision Date
March 1, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Intermedics 430-07 Bipol Implant Endocard Pac Lead received FDA clearance via the 510k pathway on March 1, 1991. Manufactured by Intermedics, it is classified as a Class III device.
What It Is
The Intermedics 430-07 Bipol Implant Endocard Pac Lead is a bipolar endocardial pacing lead designed for implantation in the heart. It facilitates electrical conduction to manage arrhythmias by delivering pacing signals to the heart muscle. This device is critical for patients with bradycardia or other rhythm disorders, ensuring proper heart rate and rhythm.
Clinical Applications
This pacing lead is commonly used in procedures involving the implantation of pacemakers. It is typically utilized in cardiology and electrophysiology settings, particularly in hospitals and specialized cardiac centers. The device is suitable for adult patients with conditions such as atrioventricular block or sick sinus syndrome, where maintaining an adequate heart rate is essential.
Indications for Use
The FDA indications for this device include use in patients who require cardiac pacing due to rhythm disorders. It is specifically indicated for those with conditions that result in a slow heart rate or irregular heartbeats.
Practical Considerations
The Intermedics 430-07 Bipol Implant Endocard Pac Lead is available in various lengths to accommodate different patient anatomies. It is compatible with most modern pacemakers and requires careful implantation technique to ensure optimal performance and patient safety.
Frequently Asked Questions
What is the Intermedics 430-07 Bipol Implant Endocard Pac Lead used for?
It is used for cardiac pacing in patients with rhythm disorders such as bradycardia.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in clinical settings.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to conditions like slow heart rate or irregular heartbeats.
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.