Ball Tip Electrode, Model #030-188

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

Full name

Ball Tip, Model #030-188

510(k) Number

K770285 ↗

FDA Product Code

DTB

FDA applicant

Med Telectronics , Ltd.

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Wedge Tip, Small, Model #030-194

  Class III

  FDA 510(k) K770283 Active Cleared 24 Feb 1977

• Wedge Tip, Small, Model #030-191

  Class III

  FDA 510(k) K770282 Active Cleared 24 Feb 1977

• Ball Tip, Model #030-185

  Class III

  FDA 510(k) K770284 Active Cleared 24 Feb 1977

• Implantable Pulse Generator

  Class III

  FDA 510(k) K770661 Active Cleared 26 Apr 1977

• What is the Ball Tip Electrode, Model #030-188, designed for in clinical use?

  The Ball Tip Electrode, Model #030-188, is specifically designed as a permanent pacemaker electrode with a ball tip for precise implantation in the cardiovascular system. Its purpose is to deliver electrical signals that help regulate heart rhythm in patients who require long-term pacing support, ensuring stable and reliable cardiac function.

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

  This device is intended for single-use only. The manufacturer supplies it sterile, and reuse is not recommended or supported by the design or regulatory classification as a permanent pacemaker electrode.

• What storage instructions should be followed for the Ball Tip Electrode, Model #030-188?

  The device must be stored strictly according to the sterile packaging instructions provided by Med Telectronics, Ltd. Proper storage ensures sterility and functionality before use, as it is supplied in a sterile condition for single-use.

• Does this device have any restrictions regarding MRI compatibility?

  The provided data does not specify MRI safety restrictions for the Ball Tip Electrode, Model #030-188. However, as with all implanted medical devices, clinicians should consult the manufacturer’s guidelines and the patient’s specific device documentation before exposing them to MRI environments to avoid potential risks.

• How is the regulatory pathway for this device defined, and what does that mean for clinicians?

  This device follows the FDA 510(k) clearance pathway, classified as a Class III medical device under the Permanent Pacemaker Electrode product code (DTB). The clearance (K770285) was granted in 1977 after review by the Cardiovascular (CV) Advisory Committee, confirming it meets FDA standards for cardiovascular devices (regulation 870.3680). Clinicians can rely on this pathway as evidence of the device’s compliance with rigorous U.S. regulatory requirements for permanent pacing applications.