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

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

510(k) Number

K930876 ↗

FDA Product Code

DTB

Models / Variants

1136T

1142T

1146T

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

• Pacing Lead Model 1188T

  Class III

  FDA 510(k) K925038 Active Cleared 15 Jul 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

• Are these leads reusable or intended for single-use only, and how should they be handled before implantation?

  These leads are explicitly designed for single-use only. They are supplied in sterile packaging and must remain unopened until ready for surgical implantation by qualified healthcare professionals. The non-sterile packaging is intended for controlled handling in a sterile field during the procedure.

• What distinguishes the different models (1136T, 1142T, and 1146T) in terms of size or configuration?

  The models differ primarily by length and electrode spacing, which are critical for proper placement in the heart. The exact specifications (e.g., total lead length, tip-to-ring distance) are detailed in the manufacturer’s product documentation, as the data provided does not list numerical values. This variability allows clinicians to select the appropriate lead for patient-specific anatomical requirements.

• Can these leads be used in patients who require MRI scans, and if so, what precautions should be taken?

  Yes, these leads are designed for use in MRI-safe environments, per the manufacturer’s specifications. However, MRI compatibility does not imply unrestricted use—clinicians must follow the manufacturer’s guidelines for MRI settings (e.g., field strength, imaging sequences) to ensure patient safety. Always verify compatibility with your MRI system’s protocols before use.

• How were these leads classified by the FDA, and what does that mean for their regulatory oversight?

  These leads fall under FDA Class III (as indicated by the device class code) and were cleared via a 510(k) pathway (K930876) under the Substantially Equivalent determination. This classification means they are subject to enhanced regulatory tracking and require compliance with stringent manufacturing controls to ensure safety and effectiveness for chronic cardiac pacing applications.

• What storage conditions are recommended for these leads before use, and how long can they remain in their packaging?

  The leads should be stored in their original sterile packaging in a clean, dry environment away from direct sunlight or extreme temperatures. While the data does not specify a shelf-life, single-use medical devices like these typically have a manufacturer-recommended expiration date printed on the packaging. Always adhere to this date to ensure sterility and performance integrity.