Pulse Generators Models 657 & 677

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

510(k) Number

K800387 ↗

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 →

• Are these pulse generators designed for reuse or are they intended for single-use implantation only?

  The Pulse Generators Models 657 & 677 are explicitly designed for single-use implantation. This is confirmed by the manufacturer’s description, which states they are ‘intended for single-use implantation’ and supplied sterile for cardiovascular procedures.

• What regulatory pathway was used for FDA clearance of these devices, and how long did the review process take?

  These devices followed the traditional 510(k) review pathway under the FDA’s pre-market notification process. The submission was received on February 22, 1980, and cleared on May 2, 1980, with a decision code indicating they were determined to be substantially equivalent to a predicate device. The review was conducted by the Cardiovascular (CV) Advisory Committee.

• What types of cardiovascular procedures are these pulse generators intended for, and how are they supplied?

  The Pulse Generators Models 657 & 677 are sterile, single-use implantable pacemaker pulse-generators intended specifically for cardiovascular procedures that require regulation of cardiac rhythm. They are supplied ready for implantation, adhering to FDA standards outlined in 21 CFR 870.3610 for implantable pacemaker pulse-generators.

• Are there multiple models available, and if so, how do they differ?

  Yes, there are two models listed: the 657 and the 677. While the data does not specify technical differences between them, both are classified under the same FDA product code (DXY) for implantable pacemaker pulse-generators and share the same regulatory clearance (K800387). Further distinctions would require additional manufacturer documentation.