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slimline unipolar endocardial pacing lead 30-402
Telectronics
Summary: The Slimline Unipolar Endocardial Pacing Lead 30-402 is a cardiac pacing lead used in patients requiring pacing therapy. It is typically used by cardiologists in hospital settings.
FDA Clearance Information
Pathway 510K
Number K853222 ↗
Decision Date September 17, 1985
Product Code DTB
Device Class Class 3
Evidence 0 studies
The Slimline Unipolar Endocardial Pacing Lead 30-402 was cleared through the FDA 510(k) pathway on September 17, 1985. It is manufactured by Telectronics and classified as a Class III device.
What It Is
The Slimline Unipolar Endocardial Pacing Lead 30-402 is a medical device used to deliver electrical impulses to the heart to maintain an adequate heart rate. It is a unipolar lead, meaning it has a single electrode that contacts the heart muscle. This device is typically implanted in patients with bradycardia or other pacing indications, helping to regulate heart rhythm.
Clinical Applications
This pacing lead is commonly used in cardiology, particularly in electrophysiology labs and during cardiac surgery. It is suitable for patients who require permanent pacing therapy, such as those with symptomatic bradycardia or heart block. The device is often used in conjunction with a pacemaker generator and is implanted in a hospital setting.
Indications for Use
The FDA indications for this device include use in patients who need cardiac pacing due to conditions like bradycardia or heart block. It helps maintain a regular heart rhythm by delivering electrical impulses to the heart.
Practical Considerations
When using the Slimline Unipolar Endocardial Pacing Lead 30-402, clinicians should consider the lead's compatibility with the pacemaker generator. Proper sizing and placement technique are crucial for optimal performance and patient safety.
Frequently Asked Questions
What is Slimline Unipolar Endocardial Pacing Lead 30-402 used for?
It is used for cardiac pacing in patients with bradycardia or heart block.
What specialties typically use this device?
Cardiologists, particularly those specializing in electrophysiology and cardiac surgery, typically use this device.
What are the FDA-cleared indications?
The device is indicated for patients requiring pacing therapy 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.