Passive Plus Endocardial Pacing Leads Var. Models

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

510(k) Number

K932892 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESP Substantially Equivalent — Postmarket Surveillance

• 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

• 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

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

  These Passive Plus Endocardial Pacing Leads are sterile and intended for single-use only, as explicitly stated in the device description. They must be handled under sterile conditions and used immediately after opening to ensure patient safety and compliance with medical device regulations.

• What types of pacing applications are these leads designed for, and where in the heart are they implanted?

  These leads are designed for endocardial implantation, meaning they are placed directly inside the heart chambers to deliver pacing stimuli. They are specifically tailored for right ventricular or atrial pacing to regulate cardiac rhythm in patients with bradycardia or conduction disorders, as described in the device’s purpose.

• How many model variants are available, and are they differentiated by specific features or electrode configurations?

  Multiple model variants exist for these leads, each tailored to specific electrode configurations and pacing applications. While exact distinctions aren’t detailed in the provided data, the 18 listed FEI numbers (e.g., 3002618605, 2183787) suggest a range of designs to accommodate different clinical needs, such as lead length, coil type, or fixation mechanisms.

• What regulatory pathway was followed for FDA clearance, and what class does this device fall under?

  The Passive Plus Endocardial Pacing Leads were cleared via the traditional 510(k) pathway (K932892) and are classified as Class 3 medical devices under FDA regulation 870.3680. This classification reflects their role in life-sustaining or supporting functions, requiring stringent oversight. The submission was reviewed by the Cardiovascular (CV) Advisory Committee in 1994.