Permanent Pacing Pad

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Oscor Medical Corp. Permanent Pacing Pad

510(k) Number

K905182 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Implant Pacing Lead Tined #3390, Modification

  Class III

  FDA 510(k) K913203 Active Cleared 23 Sep 1991

• Miscellaneous Pacing Lead

  Class II

  FDA 510(k) K925168 Active Cleared 3 May 1994

• Pacer Sensing Analyzer (Psa 100)

  Class II

  FDA 510(k) K882327 Active Cleared 6 Oct 1988

• Implant Pacemaker Lead, Tined

  Class III

  FDA 510(k) K913201 Active Cleared 23 Sep 1991

• Model Py...u Unipolar & Bipolar Pacing Lead

  Class III

  FDA 510(k) K870034 Active Cleared 3 Mar 1987

• Oscor Medical Model Tme 64S Bipolar Temp/Heart Wir

  Class II

  FDA 510(k) K850622 Active Cleared 10 Apr 1985

See all devices from Oscor Medical Corp. →

• What is the primary purpose of the Oscor Medical Corp. Permanent Pacemaker Electrode, and who would benefit from its use?

  The Oscor Medical Corp. Permanent Pacemaker Electrode is designed for implantation in the heart to deliver electrical stimulation, helping patients with bradycardia or other cardiac conduction disorders maintain a proper heart rhythm. It is intended for individuals whose natural heart rate is too slow or irregular, ensuring consistent and reliable cardiac function.

• Is this device meant for repeated use, or is it single-use only?

  This device is explicitly intended for single-use implantation only. After use, it should not be reused or reprocessed, as this could compromise patient safety and device integrity.

• How should the Permanent Pacemaker Electrode be stored to ensure sterility and functionality?

  The device must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is supplied sterile, it should remain in its original packaging until immediately before use, protected from contamination and environmental damage.

• What regulatory pathway does this device follow, and how does that affect its use?

  This device follows the FDA 510(k) clearance pathway, classified as a Class III medical device under FDA regulations. It was granted clearance under K905182 and falls under product code 870.3680. This means it has undergone rigorous review by the FDA’s Cardiovascular (CV) advisory committee to ensure safety and effectiveness for its intended use in cardiac pacing.