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model py u unipolar bipolar pacing lead
Oscor Medical
Summary: The Model PY U is a unipolar/bipolar pacing lead used in cardiac pacing procedures. It is utilized by cardiologists and electrophysiologists to maintain heart rhythm in patients with arrhythmias.
FDA Clearance Information
Pathway
510K
Number
K870034 ↗
Decision Date
March 3, 1987
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Model PY U Pacing Lead by Oscor Medical was cleared through the FDA 510(k) pathway on March 3, 1987. It is a Class III medical device under product code DTB.
What It Is
The Model PY U Pacing Lead is a specialized lead designed for cardiac pacing, available in both unipolar and bipolar configurations. It is implanted into the heart to deliver electrical impulses that regulate heartbeats in patients with arrhythmias. The lead connects to a pacemaker, which controls the timing and strength of the impulses.
Clinical Applications
This pacing lead is commonly used in procedures to treat bradycardia or other arrhythmias where pacing is required. It is typically used in settings such as hospitals or specialized cardiac centers by cardiologists and electrophysiologists. The device is suitable for a wide range of patients, including those with chronic heart conditions requiring long-term pacing support.
Indications for Use
The FDA indications suggest this device is for patients needing cardiac pacing due to arrhythmias. It is particularly useful for those with slow heart rates or irregular rhythms that require electrical stimulation to maintain a regular heartbeat.
Practical Considerations
The Model PY U Pacing Lead is available in various lengths to accommodate different patient anatomies. It is compatible with most pacemaker devices and requires careful implantation technique to ensure proper positioning and function. Clinicians should be familiar with the lead's handling characteristics and connection protocols.
Frequently Asked Questions
What is the Model PY U Pacing Lead used for?
It is used for cardiac pacing to regulate heart rhythms in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The device is indicated for patients requiring cardiac pacing due to arrhythmias, such as bradycardia.
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.