Cardiovascular Permanent Pacemaker Electrode

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

510(k) Number

K920822 ↗

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

• Passive Plus Endocardial Pacing Leads Var. Models

  Class III

  FDA 510(k) K932892 Active Cleared 6 Jul 1994

• What is the primary purpose of this Cardiovascular Permanent Pacemaker Electrode, and how is it used in clinical practice?

  This device is designed to facilitate proper cardiac rhythm in patients with bradycardia or conduction disorders by delivering electrical impulses to the heart. It acts as an interface between the pulse generator and cardiac tissue, ensuring reliable pacing support over an extended period. It is surgically implanted by qualified healthcare professionals in a sterile operating environment to maintain safety and efficacy.

• Is this device intended for single-use or can it be reused after implantation?

  The device is explicitly supplied as a single-use, sterile product. It is not intended for reuse, and proper disposal per manufacturer guidelines is required to maintain sterility and prevent contamination.

• What storage conditions should be followed for this device to ensure its integrity before use?

  While specific storage conditions are not detailed in the provided data, the device is supplied sterile and must be handled according to manufacturer guidelines to preserve sterility. It should be stored in a clean, dry environment, protected from physical damage, and kept within the expiration date to ensure optimal performance.

• How many model references are associated with this device, and why are they relevant?

  The device has multiple model references listed (e.g., 3002618605, 1028232, etc.) for regulatory tracking purposes. These references help distinguish different variants or configurations of the electrode, ensuring compliance with FDA 510(k) clearance (K920822) and facilitating proper inventory and usage in clinical settings.

• What regulatory pathway was followed for this device’s approval, and who is the applicant?

  This device followed the traditional FDA 510(k) clearance pathway, specifically under the classification of a Class III medical device. The applicant for this clearance was Siemens-Pacesetter, Inc., and the device was reviewed by the Cardiovascular (CV) Advisory Committee. The clearance number is K920822, issued on January 22, 1993.