Siemens-Elema Endocardial Lead 402S

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

510(k) Number

K803042 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Servo Gas Monitor 120

  Class II

  FDA 510(k) K861625 Active Cleared 2 May 1986

• Master Program Flow & Pressure CO2 & Lung Monitor

  Class II

  FDA 510(k) K861707 Active Cleared 19 Jun 1986

• Siemens-Elema Pulse Generator 625

  Class III

  FDA 510(k) K801508 Active Cleared 16 Sep 1980

• Endocardial Leads 414S & 515S

  Class III

  FDA 510(k) K802816 Active Cleared 16 Jan 1981

• Gas Supply Manifold Siemens-Elema Ab

  Class I

  FDA 510(k) K840326 Active Cleared 7 Jun 1984

• Pacemaker Sys. Analyzer 378

  Class II

  FDA 510(k) K832959 Active Cleared 14 Nov 1983

See all devices from Siemens Elema AB →

• What is the primary purpose of the Siemens-Elema Endocardial Lead 402S and how is it used in the body?

  The Siemens-Elema Endocardial Lead 402S is designed as a permanent pacemaker electrode to transmit electrical pacing impulses from an external pulse generator to the heart’s endocardium. It is inserted through the venous system and positioned inside the heart to help regulate cardiac rhythm by delivering consistent pacing signals, ensuring proper heart function for patients with arrhythmias or conduction disorders.

• Is the Siemens-Elema Endocardial Lead 402S intended for reuse, or is it meant for single-use only?

  The lead is supplied sterile and explicitly labeled for single-use only. This ensures patient safety by preventing contamination or degradation from repeated sterilization or reuse, which could compromise its performance or integrity.

• What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?

  The Siemens-Elema Endocardial Lead 402S received FDA clearance through a 510(k) premarket notification process, classified as a Class III device under FDA regulations. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, and the decision was determined to be substantially equivalent to a predicate device, as noted in the clearance records.

• Are there any specific storage instructions or considerations for handling this device before implantation?

  While the provided data does not specify detailed storage instructions, the lead is supplied sterile for single-use, so it should be stored in its original packaging until ready for use. Proper handling—such as avoiding contamination, extreme temperatures, or physical damage—is critical to maintaining sterility and functionality before implantation.