Silicone Elastometer Electrode Lead

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

Full name

Electrode Lead of Silicone Elastometer

510(k) Number

K823452 ↗

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 types of patients is this silicone elastomer electrode lead designed for, and how is it used in clinical practice?

  This device is designed for patients requiring long-term cardiac support, specifically those needing permanent pacing due to abnormal heart rhythms. It is implanted within the cardiovascular system to transmit electrical signals between a pacemaker generator and the heart, helping maintain proper pacing and rhythm management. The lead is intended for single-use implantation during surgery, ensuring sterile conditions for the procedure.

• How is this electrode lead supplied, and what should clinicians consider when handling it before implantation?

  The electrode lead is supplied sterile and pre-packaged for surgical use, meaning it is ready for immediate implantation without additional sterilization. Clinicians should ensure the packaging remains intact until use to maintain sterility. Since it is single-use, it should not be reused after implantation to prevent infection or device failure.

• Are there different sizes or configurations available for this lead, and how might a clinician determine the appropriate one for a patient?

  Yes, this lead is available in multiple sizes and configurations, as indicated by the registration numbers (e.g., 3002618605, 1028232). The appropriate size or model should be selected based on the patient’s anatomical needs, such as heart chamber placement (e.g., atrial or ventricular) and lead length, in consultation with the manufacturer’s guidelines or a cardiologist’s assessment.

• Can this device be used in patients who require MRI scans, and what considerations should be made if MRI is needed?

  Yes, this silicone elastomer electrode lead is compatible with MRI environments, meaning it can be used in patients who require magnetic resonance imaging. However, clinicians should follow the manufacturer’s specific MRI safety guidelines, including any recommended imaging protocols or restrictions, to ensure patient safety during the procedure.

• What regulatory pathway was followed for this device’s approval, and how does that affect its use in clinical practice?

  This device was cleared through the FDA’s 510(k) Traditional pathway, classified as a Class III device under regulation 870.3680, with a decision of