Oscor Medical Corp Permanent Pacing Lead

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

510(k) Number

K912867 ↗

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 this permanent pacing lead, and how is it intended to be used in clinical practice?

  This permanent pacing lead is designed to be implanted within the heart to deliver timed electrical impulses, helping regulate heart contractions for patients with bradycardia or conduction disorders. It is intended for chronic pacing applications, ensuring long-term cardiac rhythm support. The lead must be surgically implanted by a qualified healthcare professional under sterile conditions, as it is a single-use device.

• How is the device supplied, and what precautions should be taken during handling to maintain sterility?

  The permanent pacing lead is supplied as a sterile, pre-packaged device. Since it is intended for single-use implantation, it must be handled under sterile conditions to prevent contamination. Adherence to manufacturer guidelines for storage and handling is critical to preserve sterility and functionality before use.

• Is this device reusable, or is it meant for one-time use after implantation?

  This device is explicitly intended for single-use implantation only. Once implanted, it is not designed to be removed or reused, so proper sterile handling and disposal after use are essential.

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

  This device follows the FDA 510(k) clearance pathway, with a clearance number of K912867, and is classified as a Class III medical device. 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 chronic cardiac pacing. Clinicians can rely on this regulatory clearance as evidence of compliance with FDA standards.