Siemens-Elema Myocardial Lead

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

510(k) Number

K810036 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

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 Myocardial Lead in clinical practice?

  The Siemens-Elema Myocardial Lead is designed for implantation in the myocardium to provide electrical stimulation of the heart. It is specifically intended for use with implantable pacemaker pulse generators to help regulate cardiac rhythm in patients who require cardiac pacing support, ensuring proper heart function when natural conduction is insufficient.

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

  The Siemens-Elema Myocardial Lead is explicitly supplied as a single-use, sterile component. This design ensures patient safety and sterility, as reuse could compromise integrity and introduce infection risks, which is critical for implanted devices.

• How should the lead be stored to maintain its sterility and functionality?

  The lead must be stored and handled according to sterile medical device protocols to preserve its sterility. Since it is single-use, proper packaging and storage conditions—such as avoiding contamination, moisture, or extreme temperatures—are essential to ensure it remains viable for its intended surgical use.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Siemens-Elema Myocardial Lead received FDA 510(k) clearance under the Traditional pathway, with a decision date of January 29, 1981. This means the device was determined to be substantially equivalent to a legally marketed predicate device, allowing it to enter the market with the required regulatory approval for use in the U.S. as an implantable pacing lead.

• What types of pacemaker systems is this lead compatible with, and how is it classified under FDA regulations?

  The lead is designed for use with implantable pacemaker pulse generators and is classified as a Class III medical device under FDA regulations (product code DXY). Class III classification applies to devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. This reflects its critical role in cardiac rhythm management.