📋 FDA Reference
Oscor Medical Fix Screw Pacing Lead Peelable Cath
Oscor Medical
Summary: The Oscor Medical Fix Screw Pacing Lead is a medical device used in cardiac pacing procedures. It is primarily utilized by cardiologists and electrophysiologists for patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K861493 ↗
Decision Date ?
August 28, 1986
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Oscor Medical Fix Screw Pacing Lead was cleared through the FDA 510(k) pathway on August 28, 1986. It is manufactured by Oscor Medical and classified as a Class III device, under product code DTB.
What It Is
The Oscor Medical Fix Screw Pacing Lead is a specialized lead used in cardiac pacing systems. It features a screw mechanism that allows for secure attachment to the heart tissue, ensuring reliable electrical conduction for pacing. This device is crucial for patients with arrhythmias or heart block who require consistent cardiac rhythm management.
FDA-Cleared Indications
- Use as a pacing lead in an implantable cardiac pacemaker system when cardiac pacing is clinically indicated.
- Use for patients requiring ventricular or atrial pacing, as specified by the applicable device labeling and pacemaker system configuration.
Clinical Applications
- Placement during implantation of a permanent pacemaker system.
- Fixation of the pacing lead to cardiac tissue using its screw-in mechanism.
- Delivery of electrical pacing impulses from a compatible pacemaker generator to the heart.
- Use in cardiac electrophysiology or operating-room procedures requiring stable lead placement.
Practical Considerations
- The lead is intended for use with a compatible pacemaker generator and must be selected for the required chamber, connector, length and electrical characteristics.
- The screw-in fixation mechanism requires appropriate positioning and deployment technique under the imaging and monitoring methods specified by the device labeling.
- Available lengths and configurations may vary; clinicians should confirm current manufacturer specifications before use.
- MRI eligibility depends on the complete implanted system, including the generator, lead model and implant conditions. This historical lead should not be assumed to be MRI-conditional without verified labeling.
- Contraindications, warnings, electrical testing requirements and handling instructions should be reviewed in the current FDA-cleared labeling and manufacturer instructions.
Frequently Asked Questions
What is the Oscor Medical Fix Screw Pacing Lead used for?
It is used for cardiac pacing in patients with arrhythmias or heart block, providing reliable electrical conduction to maintain heart rhythm.
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 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.