Wedge Tip, Small, Model #030-194

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

510(k) Number

K770283 ↗

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 #030-191

  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

• 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 use of the Wedge Tip, Small (Model #030-194) pacemaker electrode, and how does its design support its function?

  The Wedge Tip, Small (Model #030-194) is designed as a permanent pacemaker electrode for cardiovascular applications, specifically implanted within the heart to deliver chronic electrical stimulation. Its wedge-tip design ensures secure anchoring in the cardiac tissue, providing stable pacing support and reliable regulation of cardiac rhythm for patients requiring long-term pacing therapy.

• Is this device intended for single-use or reusable implantation, and what precautions should be taken during handling?

  This device is sterile and intended for single-use only. It must be handled under aseptic conditions prior to surgical implantation to maintain sterility, as it is supplied in a ready-to-use configuration. Reuse is not recommended or supported by the manufacturer.

• What regulatory pathway was followed for this device, and which advisory committee reviewed its submission?

  The Wedge Tip, Small (Model #030-194) followed the FDA 510(k) traditional review pathway and was classified as a Class III medical device under regulation 870.3680. Its submission was reviewed by the Cardiovascular (CV) Advisory Committee, with a decision of substantially equivalent (SESE) to a predicate device, granting FDA clearance (K770283).

• How is this pacemaker electrode supplied, and what storage conditions should be maintained before use?

  The device is supplied sterile and ready-to-use in its packaging, eliminating the need for additional sterilization procedures. While specific storage conditions aren’t detailed, standard aseptic handling (e.g., avoiding contamination, moisture, or extreme temperatures) should be maintained until implantation to preserve sterility and functionality.