Model 030-437 Implant Electrode

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

Full name

Resubmission of Model 030-437 Implant. Electrode

510(k) Number

K870610 ↗

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

• 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

• Implantable Electrode Lead, Model 030-446

  Class III

  FDA 510(k) K874664 Active Cleared 31 May 1988

See all devices from Telectronics, Inc. →

• Is the Model 030-437 Implant Electrode designed for reuse in clinical settings, or is it intended for single-use only?

  The Model 030-437 Implant Electrode is explicitly intended for single-use implantation only. This is clearly stated in the device description, which specifies it is supplied sterile and meant for use in controlled clinical settings following standard implantation procedures for cardiac rhythm management devices. Reuse is not recommended or supported by the manufacturer.

• What types of cardiac rhythm management systems can the Model 030-437 Implant Electrode be used with, and how is it positioned within the cardiovascular system?

  The Model 030-437 Implant Electrode is designed to be part of a pacemaker or defibrillator system for cardiac rhythm management. It is intended for implantation within the cardiovascular system to deliver electrical impulses directly to the heart muscle, facilitating proper pacing or defibrillation as needed. The electrode is classified under product code DTB, which aligns with permanent pacemaker electrodes.

• How is the Model 030-437 Implant Electrode supplied, and what sterility assurances are provided?

  The Model 030-437 Implant Electrode is supplied sterile by the manufacturer, ensuring it meets clinical standards for implantation. Since it is intended for single-use in controlled settings, sterility is a critical aspect of its packaging and handling instructions, as outlined in the device description.

• What regulatory pathway was followed for the FDA clearance of this device, and when was it originally authorized?

  The Model 030-437 Implant Electrode was authorized through the FDA 510(k) clearance process (K870610) as a Class III medical device, with a decision date of March 20, 1987. It was classified as substantially equivalent (SESE) under the Cardiovascular (CV) advisory committee and falls under regulation number 870.3680. The device was originally authorized in 1987 for use in cardiac rhythm management.