Pacing Lead Model 1188T

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

510(k) Number

K925038 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

ST

• AFP Cardiac Pacing System Model 283

  Class III

  FDA 510(k) K942440 Active Cleared 8 Aug 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

• Model 1148T Transvenous, Screw-In Lead

  Class III

  FDA 510(k) K925347 Active Cleared 10 Jun 1993

• 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 clinical purpose of the Pacing Lead Model 1188T and how does it function in the body?

  The Pacing Lead Model 1188T is designed to deliver electrical stimulation to the heart for managing bradycardia or other cardiac rhythm disorders. It functions as a conductive catheter inserted through the venous system to directly interface with cardiac tissue, enabling synchronized pacing to help maintain proper heart function by compensating for irregular or slow heartbeats.

• Is the Pacing Lead Model 1188T intended for single-use or can it be reused in certain systems?

  The Pacing Lead Model 1188T is supplied sterile and intended for single-use implantation. However, the manufacturer specifies that it may be used in reusable systems under conditions outlined in their instructions, so reuse is possible in those defined scenarios.

• What sizes or models of the Pacing Lead Model 1188T are available, and how does this relate to compatibility with pacemaker systems?

  The Pacing Lead Model 1188T comes in standardized sizes to ensure compatibility with pacemaker systems. While the exact models aren’t detailed here, the lead is designed to interface seamlessly with approved pacemaker systems, adhering to industry standards for electrical and mechanical fit.

• How should the Pacing Lead Model 1188T be stored, and are there any special handling requirements?

  The Pacing Lead Model 1188T is supplied sterile, so storage should follow sterile medical device protocols to maintain integrity. The manufacturer’s instructions should be consulted for specific storage conditions, including temperature and packaging handling, to ensure the lead remains viable until use.

• Can this pacing lead be used in patients who require MRI scans, and what conditions apply?

  Yes, the Pacing Lead Model 1188T is compatible with MRI environments, but only under specific conditions outlined in the manufacturer’s instructions. These conditions likely include restrictions on MRI machine type, field strength, and patient positioning to ensure safety and functionality during imaging.