Ball Tip, Model #030-185

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

510(k) Number

K770284 ↗

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 Electrode, Model #030-188

  Class III

  FDA 510(k) K770285 Active Cleared 24 Feb 1977

• Implantable Pulse Generator

  Class III

  FDA 510(k) K770661 Active Cleared 26 Apr 1977

• What is the primary purpose of the Ball Tip, Model #030-185 pacemaker electrode, and how does its design support this function?

  The Ball Tip, Model #030-185 is designed as a permanent pacemaker electrode to facilitate reliable electrical stimulation of cardiac tissue, helping maintain proper heart rhythm. Its ball tip configuration ensures secure attachment within the heart’s chambers, which improves stability and reduces the risk of dislodgment during pacing. This design is particularly useful in cardiac electrophysiology procedures where consistent pacing is critical.

• Is this device intended for single-use or reusable applications, and what does that mean for clinical workflows?

  The Ball Tip, Model #030-185 is classified as a reusable medical device, meaning it is intended for repeated use in clinical settings after proper cleaning and sterilization. This allows for cost-effective deployment in procedures requiring permanent pacemaker electrodes, though clinicians must follow strict reprocessing protocols to ensure safety and functionality between uses.

• What regulatory pathway was followed for FDA clearance of this device, and what does that indicate about its approval status?

  This device received FDA clearance under the traditional review pathway for a 510(k) submission, with a decision date of February 24, 1977. The clearance was granted as substantially equivalent (SESE) to a predicate device, indicating the FDA determined it met the same performance criteria as an existing approved pacemaker electrode. This pathway is used for devices classified as Class III, which require stringent regulatory oversight.

• Are there any special storage requirements for the Ball Tip, Model #030-185, or does it follow standard medical device handling guidelines?

  The device description does not specify unique sterility requirements beyond standard medical device preparation, meaning it should be stored and handled according to general clinical protocols for reusable medical devices. This includes protection from contamination, proper packaging, and adherence to reprocessing guidelines to maintain its integrity for repeated use in cardiac pacing applications.

• What medical specialty is primarily responsible for using this device, and how might clinicians integrate it into their procedures?

  The Ball Tip, Model #030-185 is categorized under the medical specialty of cardiovascular, meaning it is primarily used by cardiologists and electrophysiologists. Clinicians integrate it into cardiac electrophysiology procedures—such as pacemaker implantations or replacements—to deliver consistent electrical stimulation to the heart, ensuring proper rhythm management for patients with bradycardia or other pacing-dependent conditions.