Electrode Lead Model 030-198

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K782097 ↗

FDA Product Code

DTD

Device Class

Class II

Regulation

21 CFR Part 870.3620

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 purpose of the ELECTRODE LEAD MODEL 030-198?

  This device is a pacemaker lead adaptor designed to connect electrode leads to cardiac pacing systems. It ensures the reliable transmission of electrical impulses from the pacemaker to the heart tissue, which is essential for maintaining proper cardiac rhythm in patients requiring pacing therapy.

• Who manufactured the ELECTRODE LEAD MODEL 030-198 and where is it based?

  The device was manufactured by Telectronics, Inc., a company based in Mchenry, Illinois. The manufacturer's address is listed as 803 N. Front St. Suite 3, Mchenry, IL, 60050, and the company was responsible for submitting the original 510(k) application for this device.

• Under what regulatory classification was the ELECTRODE LEAD MODEL 030-198 cleared?

  The device was cleared under the FDA 510(k) process with a determination of substantial equivalence. It is classified under product code DTD for cardiovascular devices and falls under regulation number 870.3620, which governs pacemaker lead adaptors as Class II medical devices requiring specific controls for safety and effectiveness.

• When was the ELECTRODE LEAD MODEL 030-198 approved for market entry?

  The device received FDA clearance on December 22, 1978, following a submission date of December 18, 1978. The clearance was granted under K-number K782097, indicating that the device was reviewed and found to be substantially equivalent to existing predicate devices in the cardiovascular pacing market at that time.