Implant Pacing Lead, Tined #3262, Modification

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

510(k) Number

K913202 ↗

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. →

• Is this pacing lead designed for reuse in multiple patients, or is it intended for single-use only?

  This device is explicitly intended for single-use implantation only. The documentation specifies it is supplied sterile and meant for use in a single cardiac electrophysiology procedure, ensuring patient safety and sterility standards are maintained.

• What types of cardiac procedures is this lead typically used in, and why is the tined design important?

  This lead is designed for permanent pacemaker implantation within the cardiovascular system to deliver chronic pacing stimuli. The tined design provides secure anchoring within cardiac tissue, reducing the risk of dislodgment and ensuring reliable electrical pacing over time.

• How is this device regulated, and what does the FDA’s 510(k) clearance (K913202) mean for its use?

  This device is regulated under FDA 510(k) clearance (K913202), meaning it has been determined to be substantially equivalent to a legally marketed device already on the market. The clearance confirms it meets FDA safety and effectiveness standards for permanent pacemaker electrodes, ensuring it can be legally marketed and used in clinical practice.

• Are there multiple sizes or models of this lead, and if so, how would a clinician determine the correct one for a patient?

  The provided data does not specify multiple sizes or models for this particular lead (#3262, Tined Modification). Selection would typically depend on clinical factors such as patient anatomy, pacing requirements, and physician preference, but exact sizing details would require consultation with the manufacturer’s technical documentation or product catalog.