Implant Endocardial Dish Tip Electrode

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

Full name

Implant. Endocardial Dish Tip Elect. Lds

510(k) Number

K802413 ↗

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 this endocardial electrode, and how does its dish-shaped tip contribute to its function?

  This device is designed for permanent pacemaker implantation to facilitate cardiac pacing and rhythm management in patients with conduction disorders. The dish-shaped tip provides stable electrical contact with the endocardium, ensuring reliable pacing and reducing the risk of dislodgment during implantation.

• Is this electrode intended for single-use or reusable applications, and how should it be stored to maintain sterility?

  The electrode is supplied sterile and intended for single-use implantation only. To maintain sterility and functionality, it must be stored according to the manufacturer’s guidelines, which likely include protection from contamination, extreme temperatures, and physical damage until use.

• What compatibility considerations should clinicians keep in mind when using this device, particularly regarding imaging procedures?

  This electrode is classified as MRI-compatible under OpenFDA’s registry, meaning it can be used in patients who require magnetic resonance imaging. However, proper handling and adherence to manufacturer instructions are still required to ensure safety and performance during MRI procedures.

• How is this device regulated, and what does the FDA’s 510(k) clearance (K802413) indicate about its approval process?

  The device holds FDA 510(k) clearance (K802413), meaning it was determined to be *substantially equivalent* to a legally marketed predicate device through a traditional review process. This classification ensures it meets regulatory standards for safety and effectiveness as a permanent pacemaker electrode under Device Type DTB (870.3680).