Pulse Generator Model 637

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

510(k) Number

K790792 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lead Modification

  Class III

  FDA 510(k) K770135 Active Cleared 7 Feb 1977

• Pulse Generator Model 629

  Class III

  FDA 510(k) K790670 Active Cleared 27 Jun 1979

• Puck 90M

  Class II

  FDA 510(k) K903576 Active Cleared 4 Sep 1990

• Sep Programmer for Puck U & Ud Filmchang

  Class II

  FDA 510(k) K842903 Active Cleared 21 Aug 1984

• Sep Programmer Sep-M/Single-Plane &

  Class II

  FDA 510(k) K840389 Active Cleared 21 Feb 1984

• Pacemaker 208S

  Class III

  FDA 510(k) K770005 Active Cleared 24 Feb 1977

See all devices from Elema-Schonander, Inc. →

• What is the primary purpose of the Pulse Generator Model 637 in a clinical setting?

  The Pulse Generator Model 637 is designed as an implantable pacemaker pulse-generator, which regulates cardiac rhythm by delivering controlled electrical impulses to the heart. It is specifically intended for use in cardiovascular settings to support or sustain heart function in patients with abnormal heartbeats or conduction issues.

• Is the Pulse Generator Model 637 intended for single-use or can it be reused?

  The provided data does not specify sterility or single-use requirements for the Pulse Generator Model 637. However, it is described as a reusable component within a pacemaker system, meaning it is not intended for single-use disposal. Proper sterilization and maintenance protocols would apply for reuse in clinical settings.

• How is the regulatory status of this device determined, and what does that mean for clinicians?

  The Pulse Generator Model 637 is classified as a Class III medical device under FDA regulations, requiring stringent oversight due to its role in life-sustaining functions. It was granted FDA 510(k) clearance (K790792) in 1979, with a decision of Substantially Equivalent to a predicate device. This means it has been evaluated for safety and effectiveness and is authorized for use in the U.S. under 21 CFR 870.3610, ensuring compliance with regulatory standards for pacemaker pulse-generators.

• What types of facilities or specialties would typically use this device?

  The Pulse Generator Model 637 is explicitly associated with cardiovascular specialties and is intended for use in settings where pacemaker implantation or cardiac rhythm management is performed. This includes electrophysiology labs, cardiac catheterization labs, and hospitals with dedicated cardiac care units, where trained clinicians—such as cardiologists, electrophysiologists, or cardiac surgeons—would implant and manage the device.

• Are there any known variations or models associated with this Pulse Generator, and how are they identified?

  The provided data lists multiple registration numbers (e.g., 2017865, 3005334138, etc.) and FEI numbers (e.g., 3002807576, 2017865) linked to the Pulse Generator Model 637, which may correspond to different lots, revisions, or related devices under the same product code (DXY). These identifiers are used for tracking and regulatory purposes but do not imply distinct clinical models. Clinicians or buyers should verify specific lot details with the manufacturer if precise model variations are required.