Implantable Electrode Lead 030-272 Using Polyureth

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

510(k) Number

K851294 ↗

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 030-272 and how does it function in the body?

  The IMPLANTABLE ELECTRODE LEAD 030-272 is designed for chronic cardiac pacing, acting as a conduit between an implanted pulse generator and the heart. It transmits electrical signals to regulate and maintain proper cardiac rhythm in patients who require long-term pacing support, ensuring consistent 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. It is supplied sterile and must be handled and stored according to manufacturer guidelines to preserve sterility and functionality, as reuse is not recommended.

• What type of regulatory clearance does this device hold, and under which medical specialty is it classified?

  The IMPLANTABLE ELECTRODE LEAD 030-272 holds FDA 510(k) clearance (K851294) and is classified under the Cardiovascular medical specialty. It is also designated as a Class III medical device, reflecting its critical role in life-sustaining or supporting functions.

• How should this device be stored to ensure it remains sterile and functional before use?

  The device must be stored according to the manufacturer’s guidelines to maintain sterility and functionality. Since it is supplied sterile and intended for single-use, it should be kept in its original packaging until immediately before use in a sterile surgical setting, avoiding exposure to contaminants or environmental factors that could compromise its integrity.

• Are there any specific warnings or considerations regarding the use of this device in relation to MRI procedures?

  The available data does not specify any MRI safety information for this device. Clinicians should consult the manufacturer’s instructions or additional documentation to determine compatibility with MRI procedures, as the lead’s polyurethane construction may pose risks in magnetic fields.