Implantable Electrode Lead 030-269 Using Polyureth

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

510(k) Number

K851296 ↗

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 IMPLANTABLE ELECTRODE LEAD 030-269 and how does it function within the body?

  The IMPLANTABLE ELECTRODE LEAD 030-269 is designed to facilitate cardiac pacing by delivering electrical impulses to the heart. It is implanted within the cardiovascular system to help regulate heart rhythm in patients with bradycardia (slow heart rate) or conduction disorders, ensuring proper heart function.

• Is this device intended for single-use or can it be reused after implantation?

  This device is explicitly intended for single-use implantation only. The manufacturer specifies it as a one-time-use lead, meaning it should not be reused after surgical placement.

• How is the IMPLANTABLE ELECTRODE LEAD 030-269 supplied, and what precautions should be taken during handling?

  The device is supplied sterile for surgical implantation in controlled clinical settings like cardiac catheterization labs or operating rooms. Since it is single-use, sterile barriers must remain intact until use, and proper aseptic techniques should be followed to prevent contamination.

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

  The IMPLANTABLE ELECTRODE LEAD 030-269 was cleared through the FDA 510(k) pathway under the Traditional review process, with a decision classified as *Substantially Equivalent*. The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III medical device.

• What product code and registration numbers are associated with this device for regulatory tracking?

  This device falls under the Permanent Pacemaker Electrode product code (DTB) and is associated with multiple FDA registration numbers, including 2017865, 2032521, 9610139, and others listed under the OpenFDA entry (e.g., 3002618605, 3008377825). These identifiers are used for regulatory tracking and compliance.