Implant Pacemaker Lead, Tined

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

Full name

Products Implant Pacing Lead, Tined, Modification

510(k) Number

K913201 ↗

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

• 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

• Implant Pacing Lead, Tined #3262, Modification

  Class III

  FDA 510(k) K913202 Active Cleared 23 Sep 1991

See all devices from Oscor Medical Corp. →

• What is the primary purpose of this tined pacing lead, and how does the tined design benefit patients?

  This device is a permanent pacemaker electrode designed for transvenous implantation to deliver electrical stimulation to the heart. The tined design enhances fixation within cardiac tissue, ensuring stable positioning for chronic pacing applications in patients with bradycardia or conduction disorders. The tines help secure the lead in place, reducing the risk of displacement over time.

• Is this lead intended for reuse, or is it meant for single-use only? How should it be handled before implantation?

  The lead is sterile and intended for single-use only, meaning it must be used once and then discarded. It is supplied pre-sterilized for clinical settings like cardiac catheterization labs or operating rooms, where qualified healthcare professionals perform the implantation.

• What regulatory pathway was followed for FDA clearance, and how does this affect its classification?

  This device received FDA 510(k) clearance through a traditional review pathway under the Cardiovascular advisory committee. It is classified as a Class III device (regulation 870.3680), meaning it is subject to stricter regulatory oversight due to its role in life-sustaining or life-supporting functions. The clearance was granted as substantially equivalent to a predicate device.

• Are there multiple model variants of this lead, and if so, how are they differentiated for regulatory tracking?

  Yes, this lead has multiple model references tracked via FDA Establishment Inspection Report (FEI) numbers, including identifiers like 2017865, 3002618605, and others. These numbers are used for regulatory tracking and compliance but do not indicate functional or clinical differences—each FEI corresponds to a specific batch or variant as filed with the FDA.

• Where should this lead be stored before use, and are there any special handling instructions?

  Since the lead is sterile and single-use, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging must remain intact until implantation to maintain sterility. Always follow manufacturer instructions for storage conditions, which are typically detailed on the packaging.