Implantable Electrode Lead, Model 030-439

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

510(k) Number

K864618 ↗

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 clinical purpose of the Model 030-439 Implantable Electrode Lead, and how is it positioned within the body during use?

  The Model 030-439 Implantable Electrode Lead is designed to deliver electrical impulses to the heart as part of a cardiac pacing system. It is intended for subcutaneous or intracardiac implantation to establish electrical continuity between a pacemaker generator and cardiac tissue, helping regulate heart rhythm in patients with bradycardia or conduction disorders.

• Is the Model 030-439 lead intended for single-use or reusable applications, and how should it be stored before use?

  The Model 030-439 is explicitly intended for single-use implantation only. Prior to use, it must be stored in a way that protects it from moisture and mechanical damage, as outlined in the device documentation.

• What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?

  The Model 030-439 received FDA clearance through a Traditional 510(k) pathway (K864618) with a decision of *Substantially Equivalent*. The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a high-risk Class III device under regulatory nomenclature.

• How is the sterility of the Model 030-439 lead ensured, and what does this imply for clinical handling?

  The lead is supplied sterile, meaning it is pre-sterilized and packaged to maintain sterility until use. This ensures a clean surgical field during implantation, reducing infection risks. Clinicians should follow manufacturer guidelines for opening the sterile packaging and handling to preserve sterility.