📋 FDA Reference
Implantable Pacing Lead Tined 3390
Summary: The implantable pacing lead tined 3390 by Oscor is a cardiac device used to deliver electrical impulses to the heart. It is primarily used by cardiologists in patients requiring cardiac pacing.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K823448 ↗
Decision Date ?
December 3, 1982
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The implantable pacing lead tined 3390 was cleared through the FDA 510k pathway on December 3, 1982. Manufactured by Oscor, it is classified as a Class 3 medical device.
What It Is
The implantable pacing lead tined 3390 is a medical device designed to provide electrical stimulation to the heart muscle, ensuring proper heart rhythm. It features tines that help secure the lead in place within the heart. This lead is typically used in conjunction with a pacemaker to manage arrhythmias by delivering consistent electrical impulses.
FDA-Cleared Indications
- Cardiac pacing in patients who require electrical stimulation to maintain an adequate heart rate.
- Placement in the atrium or ventricle when indicated for the patient's pacing treatment.
Clinical Applications
- Connecting an implanted pacemaker generator to the heart for cardiac pacing.
- Providing atrial pacing when atrial stimulation is clinically indicated.
- Providing ventricular pacing when ventricular stimulation is clinically indicated.
- Use during acute or chronic pacing treatment according to the applicable pacemaker system labeling.
Practical Considerations
- The lead uses tines to help maintain its position within the heart.
- Lead length and configuration must be selected to match the patient's anatomy and the intended atrial or ventricular placement.
- The lead must be used with a compatible pacemaker system and connector configuration.
- MRI safety cannot be determined from this historical device record alone; the complete implanted system must be evaluated against current manufacturer and MRI-conditional labeling.
- Implantation requires appropriate cardiac imaging, lead-testing, sterile technique, and assessment for complications such as dislodgement, perforation, infection, or abnormal electrical performance.
Frequently Asked Questions
What is the implantable pacing lead tined 3390 used for?
It is used to deliver electrical impulses to the heart to maintain proper heart rhythm in patients with arrhythmias.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in settings like hospitals and specialized cardiac centers.
What are the FDA-cleared indications?
It is indicated for patients requiring cardiac pacing due to conditions like 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.