Implantable Electrode Lead, Model 030-436

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

510(k) Number

K861767 ↗

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 Model 030-436 implantable electrode lead, and how does it function in a patient’s body?

  The Model 030-436 is a permanent pacemaker electrode lead designed to deliver controlled electrical impulses directly to the heart. It is used in cardiac rhythm management systems to stimulate the heart muscle and correct bradycardia (slow heart rate) or conduction disorders by ensuring proper pacing and maintaining a regular heartbeat.

• Is this device intended for reuse, or is it meant to be implanted once and discarded?

  This device is sterile and intended for single-use only. After implantation, it should not be reused, as reuse could compromise sterility and patient safety. The packaging ensures it remains sterile until use, requiring no reprocessing.

• What regulatory pathway was followed for FDA clearance, and what does that mean for its use in clinical settings?

  The Model 030-436 received FDA clearance via the Traditional 510(k) pathway in 1986, with a clearance number of K861767. This means it was determined to be substantially equivalent to a legally marketed predicate device, confirming its safety and effectiveness for its intended use in cardiac pacing procedures. Clinicians can rely on this clearance as evidence of regulatory review.

• What types of cardiovascular procedures is this lead designed for, and how should it be handled before implantation?

  This lead is specifically designed for implantation in cardiac rhythm management systems, particularly for patients requiring pacing due to bradycardia or conduction disorders. It must be handled under sterile conditions prior to use, as it is supplied sterile and intended for a single-use procedure. Any breach of sterility before implantation could risk infection or complications.