Model 1148T Transvenous, Screw-In Lead

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

510(k) Number

K925347 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• AFP Cardiac Pacing System Model 283

  Class III

  FDA 510(k) K942440 Active Cleared 8 Aug 1994

• Pacing Lead Model 1188T

  Class III

  FDA 510(k) K925038 Active Cleared 15 Jul 1994

• Silicone Bipolar Lead Models 1136T, 1142T &1146T

  Class III

  FDA 510(k) K930876 Active Cleared 15 Jun 1994

• Adapting Sleeve Kit Model 4023

  Class II

  FDA 510(k) K921318 Active Cleared 3 Aug 1992

• Cardiovascular Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K920822 Active Cleared 22 Jan 1993

• Passive Plus Endocardial Pacing Leads Var. Models

  Class III

  FDA 510(k) K932892 Active Cleared 6 Jul 1994

• What is the primary purpose of the Model 1148T Transvenous, Screw-In Lead, and how does it differ from other pacing leads?

  The Model 1148T is designed specifically for transvenous implantation in the right ventricle, where its screw-in mechanism provides secure fixation to deliver chronic cardiac pacing. Unlike some leads that rely on passive fixation (e.g., tines or cuffs), this screw-in design ensures stable positioning for long-term rhythm management in patients requiring consistent electrical stimulation.

• Is this lead intended for reuse, or is it meant to be used only once? How should it be handled to maintain safety?

  The Model 1148T is sterile and intended for single-use only. To preserve sterility and functionality, it must be handled using aseptic techniques and stored according to the manufacturer’s instructions—typically in its original packaging until immediately before use, avoiding contamination or exposure to moisture or pressure.

• What regulatory pathway was followed for FDA clearance, and what does this mean for clinicians or hospitals?

  The Model 1148T received FDA 510(k) clearance (K925347) under the Traditional 510(k) pathway, demonstrating it is substantially equivalent to a predicate device. This means it meets FDA standards for safety and effectiveness as a Class III Permanent Pacemaker Electrode (21 CFR 870.3680) and is approved for use in cardiovascular procedures requiring chronic pacing. Hospitals can proceed with purchase and implantation with confidence in its regulatory standing.

• Are there different sizes or models of this lead, or is it a single configuration?

  The provided data does not specify multiple sizes or models for the Model 1148T, implying it is a standardized transvenous screw-in lead. However, the OpenFDA registration numbers suggest it may have been distributed in various lot configurations or packaging sizes. For exact sizing (e.g., lead length, coil diameter), refer to the manufacturer’s product documentation or catalog.