Laserdish Poly Unipolar Ventri Lead W/Trail Tines

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

510(k) Number

K904741 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 100 cm Permanent Pacing Lead Models

  Class III

  FDA 510(k) K911273 Active Cleared 28 Aug 1991

• Pellethan Adhesive on Polyurethane Leads-MODI

  Class III

  FDA 510(k) K893041 Active Cleared 14 Nov 1989

• Optima MPT Model 5281E and Model 5282E

  Class III

  FDA 510(k) K897116 Active Cleared 14 Mar 1990

• Telectronics Pacing Systems Vs-1 to 6mm Upsizing

  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. →

• Is this lead designed for reuse after implantation, or is it intended for single-use only?

  This device is explicitly intended for single-use implantation only. The manufacturer states it is supplied sterile and does not require additional sterilization or reprocessing post-implantation, confirming it is not meant to be reused.

• What materials is the lead constructed from, and how does that affect its use?

  The lead is constructed from a poly material, which refers to a polyurethane-based composition. This material is chosen for its durability, biocompatibility, and ability to provide stable fixation within the ventricular chamber, ensuring reliable pacing stimuli delivery over time.

• What specific features of this lead help ensure stable placement in the heart?

  The lead includes trailing tines, which are designed to enhance fixation within the heart’s ventricular chamber. These tines help anchor the electrode securely, reducing the risk of displacement and ensuring consistent pacing performance.

• How is this device regulated, and what does that mean for its use in clinical settings?

  This device is classified as a Class III medical device under 21 CFR 870.3680 and has been cleared via the FDA 510(k) pathway (K904741). This means it undergoes rigorous review by the FDA’s Cardiovascular (CV) advisory committee to ensure safety and effectiveness for its intended use in cardiac pacing procedures.

• What storage or handling precautions should be taken with this lead before implantation?

  Since the lead is supplied sterile, it should be stored in its original packaging until use to maintain sterility. The manufacturer does not specify additional handling requirements beyond standard sterile medical device protocols, so proper aseptic techniques should be followed during implantation.