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perm inplant endocard pac lead
Daig
Summary: The perm implant endocard pac lead by Daig is a cardiac pacing lead used in patients requiring permanent cardiac pacing. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K800347 ↗
Decision Date
May 28, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The perm implant endocard pac lead was cleared via the FDA 510k pathway on May 28, 1980. It is manufactured by Daig and classified as a Class III device.
What It Is
The perm implant endocard pac lead is a medical device used in cardiac pacing systems. It is designed to deliver electrical impulses to the heart to maintain an adequate heart rate in patients with arrhythmias or heart block. The lead is implanted into the heart's endocardial surface and connected to a pacemaker, which regulates the heart's rhythm.
Clinical Applications
This device is commonly used in patients with bradycardia, heart block, or other conditions requiring permanent pacing. It is typically utilized in cardiology and electrophysiology specialties. The procedure is performed in a hospital setting, often in a cardiac catheterization lab or operating room, and is used in adult and elderly patient populations.
Indications for Use
The perm implant endocard pac lead is indicated for patients who need long-term cardiac pacing due to conditions like slow heart rates or heart block. It helps maintain a regular heart rhythm by delivering electrical impulses directly to the heart.
Practical Considerations
When using the perm implant endocard pac lead, clinicians should consider the appropriate lead size and compatibility with the pacemaker device. Proper implantation technique is crucial to ensure effective pacing and minimize complications.
Frequently Asked Questions
What is perm implant endocard pac lead used for?
It is used for permanent cardiac pacing in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiology and electrophysiology specialists typically use this device.
What are the FDA-cleared indications?
It is indicated for patients requiring long-term cardiac pacing due to conditions like bradycardia or heart block.
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.