Endocardial Leads 414S & 515S

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

510(k) Number

K802816 ↗

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

• 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

• Siemens-Elema Ab Manual Ventilation

  Class II

  FDA 510(k) K800114 Active Cleared 5 Mar 1980

See all devices from Siemens Elema AB →

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

  The Endocardial Leads 414S & 515S are explicitly designed for single-use implantation and are supplied sterile. They must be handled according to manufacturer guidelines to preserve sterility and functionality, ensuring they are only used once per patient during a cardiac procedure.

• What types of cardiac procedures are these leads intended for, and how are they placed?

  These leads are intended for endocardial placement, meaning they are implanted directly into the heart muscle to facilitate chronic cardiac pacing in patients requiring rhythm management. They are conductive components that transmit electrical impulses from an implanted pacemaker, making them suitable for procedures involving permanent pacemaker systems.

• Are there different sizes or models available, and if so, how do they differ?

  The Endocardial Leads 414S & 515S are listed as distinct models, but the provided data does not specify exact differences in size, electrode design, or pacing capabilities. Clinicians should refer to the manufacturer’s documentation for detailed technical distinctions, such as lead length, coil configurations, or tine designs, which may influence selection for specific patient anatomies or pacing needs.

• How should these leads be stored to maintain their integrity and sterility before use?

  The manufacturer’s guidelines must be followed for storage to ensure sterility and functionality are maintained. While the data does not specify exact conditions (e.g., temperature, humidity), standard practices for sterile single-use medical devices—such as keeping them in sealed, unopened packaging and avoiding contamination—should be applied. Always check the packaging for any additional storage instructions.

• What regulatory pathway was used for FDA clearance, and what does this mean for clinicians or buyers?

  The Endocardial Leads 414S & 515S were cleared via the 510(k) pathway in 1981, with a determination of substantial equivalence to a predicate device. This means the FDA found them to have the same intended use and technological characteristics as a previously cleared device, ensuring they meet safety and effectiveness standards for permanent pacemaker electrodes. Clinicians or buyers can rely on this clearance as evidence of regulatory review, though ongoing adherence to manufacturer instructions is still required.