Implantable Electrode Lead, Model 030-400

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

510(k) Number

K852972 ↗

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 purpose of the IMPLANTABLE ELECTRODE LEAD, Model 030-400, and how does it function within a pacemaker system?

  The IMPLANTABLE ELECTRODE LEAD, Model 030-400, is designed to transmit electrical signals between a pacemaker pulse generator and heart tissue, ensuring proper heart rhythm regulation. It is implanted surgically to facilitate cardiac pacing, acting as a critical component in maintaining consistent and effective heart contractions for patients with abnormal heart rhythms.

• Is the IMPLANTABLE ELECTRODE LEAD, Model 030-400, intended for single-use or can it be reused?

  The device is explicitly described as a reusable component within a pacemaker system. However, it must be handled using aseptic techniques during implantation and subsequent use to prevent infection, as it is intended for sterile surgical implantation by qualified healthcare professionals.

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

  The IMPLANTABLE ELECTRODE LEAD, Model 030-400, was cleared through the FDA’s 510(k) process, specifically under the Traditional pathway, with a decision of Substantially Equivalent (SESE). This means the device was determined to be at least as safe and effective as a legally marketed predicate device, allowing it to be marketed in the U.S. for its intended use in cardiac pacing.

• How should this device be stored, and are there any specific handling instructions provided?

  While the provided data does not specify storage conditions explicitly, the device is intended for sterile surgical implantation and must be handled with aseptic techniques. This implies it should be stored in a clean, controlled environment to maintain sterility and integrity until use, following standard medical device storage protocols for implantable components.

• What medical specialty is primarily responsible for the use of this device, and why?

  The device falls under the medical specialty of Cardiovascular, as indicated in the regulatory data. This is because the IMPLANTABLE ELECTRODE LEAD, Model 030-400, is specifically designed for cardiac pacing, which is a core function within cardiovascular medicine, typically managed by cardiologists or electrophysiologists.