Slimline Unipolar Endocardial Pacing Lead #30-402

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

510(k) Number

K853222 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

See all devices from Telectronics, Inc. →

• What is the primary use of the Slimline Unipolar Endocardial Pacing Lead #30-402, and how does it function within the body?

  The Slimline Unipolar Endocardial Pacing Lead #30-402 is designed for permanent endocardial pacing, delivering electrical stimulation to the heart muscle via a single electrode. It is implanted within the heart chambers to regulate cardiac rhythm in patients who require pacing support, such as those with bradycardia or conduction system disorders. The unipolar design means it relies on a single electrode (cathode) with the patient’s body serving as the return path (anode), ensuring precise pacing impulses to maintain a stable heartbeat.

• Is this device intended for reuse, or is it meant to be used only once after implantation?

  The Slimline Unipolar Endocardial Pacing Lead #30-402 is sterile and intended for single-use only. Once implanted, it remains in the patient’s body permanently as part of a pacemaker system, so it is not designed for removal or reuse in another patient. Sterility ensures safety during the initial procedure, and its permanent nature aligns with standard clinical practice for endocardial pacing leads.

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

  The device is supplied sterile and packaged for single-use, meaning it is ready for immediate use in the operating room without additional sterilization. Clinicians should handle it with sterile techniques to avoid contamination, as it is not meant to be reprocessed. The packaging ensures the lead remains uncontaminated until implantation, adhering to best practices for invasive cardiac procedures.

• What regulatory pathway was followed for this device’s FDA clearance, and what does that mean for its safety and efficacy?

  The Slimline Unipolar Endocardial Pacing Lead #30-402 received FDA clearance through the Traditional 510(k) pathway (K853222), with a decision of *Substantially Equivalent* to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for permanent pacemaker electrodes. The clearance was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III device under FDA regulations.