Laserdish Silicone Ventricular Lead W/Trailing Tin

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

510(k) Number

K903221 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class III

  FDA 510(k) K911273 Active Cleared 28 Aug 1991

• Pellethan Adhesive on Polyurethane Leads-MODI

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  Class II

  FDA 510(k) K895971 Active Cleared 22 Feb 1990

• Bifurcated Vs-1 to Vs-1 Lead Adaptor

  Class II

  FDA 510(k) K910112 Active Cleared 25 Feb 1991

• Vs-1 Lead Ext. 033-302, 4.75mm 033-260, 033-458

  Class III

  FDA 510(k) K901402 Active Cleared 12 Jun 1990

See all devices from Telectronics Pacing Systems, Inc. →

• What is the primary purpose of the Laserdish Silicone Ventricular Lead with Trailing Tin in clinical practice?

  This device is designed as a permanent pacemaker electrode specifically for ventricular lead placement. It delivers electrical stimulation to regulate heart rhythm in patients with bradycardia or other pacing-related conditions by implanting within the heart to ensure consistent pacing support.

• Is this lead intended for single-use or reusable applications, and how is it packaged?

  The Laserdish Silicone Ventricular Lead is sterile and intended for single-use only after implantation. It is supplied in sterile packaging, ensuring readiness for surgical use without requiring reprocessing.

• What regulatory pathway was followed for FDA clearance of this ventricular lead?

  This device received FDA clearance through a Traditional 510(k) pathway (K903221), classified as a Class III device under FDA regulations. It adheres to the DTB product code and 870.3680 regulatory standards, with a decision of *Substantially Equivalent* by the Cardiovascular (CV) Advisory Committee.

• What materials is the lead constructed from, and how does the trailing tin component contribute to its function?

  The lead is constructed primarily from silicone, a durable and biocompatible material ideal for long-term cardiac implantation. The trailing tin component likely serves as a conductive element, ensuring reliable electrical contact for pacing stimuli within the heart’s ventricular chamber.

• How should this lead be stored before use, given its sterile and single-use nature?

  Since the lead is sterile and single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Follow manufacturer guidelines to preserve sterility until immediate preoperative use.