Laserdish Polyurethane Ventricular Lead W/Trailing

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

510(k) Number

K900645 ↗

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. →

• What is the primary purpose of the LASERDISH Polyurethane Ventricular Lead with Trailing, and how does it function in the body?

  The LASERDISH Polyurethane Ventricular Lead is designed specifically for ventricular pacing to regulate heart rate in patients with arrhythmias or conduction disorders. It delivers electrical stimulation directly to the heart’s ventricles through chronic implantation, ensuring proper cardiac function by maintaining synchronized contractions.

• Is this device intended for single-use or reusable implantation, and why does that matter?

  This lead is explicitly intended for single-use implantation, meaning it is not designed to be removed and reused. This is critical because sterility and proper handling are essential for preventing infection during the minimally invasive procedure, ensuring patient safety during chronic use.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians?

  The device received FDA clearance via a 510(k) submission (K900645), classified as a Class III medical device under regulation 870.3680 for pacemaker leads. This means it underwent a traditional review process by the FDA’s Cardiovascular (CV) Advisory Committee to demonstrate substantial equivalence to a predicate device, ensuring it meets strict safety and effectiveness standards for ventricular pacing applications.

• How is the lead supplied, and what should clinicians consider when handling it before implantation?

  The lead is supplied as a sterile, single-use device for direct implantation into the heart’s ventricle. Clinicians must adhere to strict sterility protocols during handling to prevent contamination, as improper handling could compromise patient safety during the procedure. The polyurethane construction also requires careful manipulation to avoid damage before use.