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oscor medical corp permanent pacing pad
Oscor Medical
Summary: The Permanent Pacing Pad by Oscor Medical is a Class III medical device used primarily in cardiac procedures to provide temporary pacing. It is utilized by cardiologists and cardiac surgeons in hospital settings.
FDA Clearance Information
Pathway
510K
Number
K905182 ↗
Decision Date
May 7, 1991
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Permanent Pacing Pad was cleared through the FDA 510(k) pathway on May 7, 1991. Manufactured by Oscor Medical, it is classified as a Class III device under product code DTB.
What It Is
The Permanent Pacing Pad is a medical device designed to provide temporary cardiac pacing during procedures where the heart's natural pacing is inadequate. It works by delivering electrical impulses to stimulate the heart muscle, ensuring proper cardiac function. This device is crucial in managing patients with bradycardia or during surgeries that may affect heart rhythm.
Clinical Applications
This device is commonly used in cardiac catheterization labs and during open-heart surgeries. It is essential for patients undergoing procedures that may disrupt normal heart rhythms, such as those with heart block or post-cardiac surgery. Cardiologists and cardiac surgeons use it to maintain hemodynamic stability in patients with compromised cardiac function.
Indications for Use
The Permanent Pacing Pad is indicated for patients requiring temporary cardiac pacing. This includes individuals with bradycardia or those undergoing surgical procedures that risk disrupting normal heart rhythms.
Practical Considerations
The device is typically available in various sizes to accommodate different patient anatomies. It is compatible with standard pacing generators and requires careful placement to ensure effective pacing. Clinicians should be trained in its application and monitoring.
Frequently Asked Questions
What is the Permanent Pacing Pad used for?
It is used for temporary cardiac pacing in patients with bradycardia or during surgeries affecting heart rhythm.
What specialties typically use this device?
Cardiologists and cardiac surgeons primarily use this device in hospital settings.
What are the FDA-cleared indications?
It is indicated for temporary cardiac pacing in patients with disrupted heart rhythms or during 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.