Oscor Medical Implantable Pacing Lead, Retractable

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

510(k) Number

K850623 ↗

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 Retractable Implantable Pacing Lead, and who is it designed for?

  The Oscor Medical Retractable Implantable Pacing Lead is designed to deliver electrical impulses to the heart muscle, helping regulate heart rhythm in patients with bradycardia or conduction system disorders. It is intended for implantation within the cardiovascular system to ensure proper cardiac function through controlled stimulation, making it suitable for patients requiring permanent pacemaker support.

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

  This device is explicitly designed for single-use implantation only. It is supplied sterile and packaged for surgical use, requiring careful handling to maintain sterility. Reuse is not recommended or supported by the manufacturer.

• What sizes or models are available for the Oscor Medical Retractable Implantable Pacing Lead?

  The provided data lists multiple FEI numbers (e.g., 3002618605, 1028232, etc.), which correspond to different product variants or lot identifiers. These likely represent different batch or model-specific identifiers, but the exact sizing (e.g., lead length, coil diameter, or electrode configuration) is not detailed in the data. For precise sizing options, refer to the manufacturer’s technical documentation or catalog.

• How should the device be stored to ensure it remains sterile and functional?

  The device is supplied sterile and packaged for surgical use, so it must be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should be kept intact until immediate preoperative use to preserve sterility and integrity.

• What regulatory pathway was followed for this device’s approval, and how is it classified?

  The device underwent a Traditional 510(k) review through the FDA’s Cardiovascular (CV) Advisory Committee, receiving clearance under K850623. It is classified as a Class III medical device under 21 CFR 870.3680, indicating it is subject to stringent regulatory oversight due to its role in life-sustaining or life-supporting functions.