Implantable Electrode Lead, Model 030-446

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

510(k) Number

K874664 ↗

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 030-446 Implantable Electrode Lead, and how does it function within a pacemaker system?

  The Model 030-446 is designed as a permanent pacemaker electrode lead to regulate abnormal heart rhythms by delivering timed electrical impulses to the heart muscle (myocardium). It works in conjunction with a pacemaker system, transmitting electrical signals directly to the heart to maintain proper pacing when the heart’s natural rhythm is disrupted.

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

  The Model 030-446 is sterile and intended for single-use only. After implantation, it should not be reused, as this could compromise patient safety and sterility.

• What type of regulatory clearance does this device hold, and how was it approved by the FDA?

  The Model 030-446 was cleared by the FDA under a Traditional 510(k) pathway (K874664) in 1988. It is classified as a Class 3 device under FDA regulations (870.3680), meaning it was determined to be substantially equivalent to a legally marketed predicate device at the time of clearance.

• How should this device be stored before use, given its sterile packaging?

  Since the Model 030-446 is supplied sterile, it must be stored in its original, unopened packaging until ready for use. The packaging should be kept dry, protected from contamination, and away from extreme temperatures or direct sunlight to maintain sterility.