Wedge Tip, Small, Model #030-191

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

510(k) Number

K770282 ↗

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

• 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 purpose of the Wedge Tip, Small (Model #030-191) pacemaker electrode, and where is it typically implanted?

  The Wedge Tip, Small (Model #030-191) is designed for implantation within the cardiovascular system to provide mechanical stability for pacing applications. Its wedge-shaped tip is specifically intended to anchor securely in the inferior vena cava or related venous structures, ensuring reliable positioning for long-term pacemaker function.

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

  This device is sterile and intended for single-use implantation only. To preserve sterility before use, it must be stored and handled using aseptic techniques, following manufacturer guidelines to prevent contamination.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Wedge Tip, Small (Model #030-191) received a Traditional 510(k) clearance (K770282) under the FDA’s substantial equivalence determination. It is classified as a Class III medical device (21 CFR 870.3680), reflecting its role in life-sustaining or supporting cardiovascular applications.

• Does this device require any special handling or preparation before implantation, beyond standard sterile procedures?

  Beyond standard aseptic techniques, the device is pre-sterilized and packaged for single-use, so no additional sterilization or reprocessing is required. However, adherence to manufacturer instructions for unpacking and implantation is critical to ensure sterility and proper function.