MICROLITH MODELS 505 - 507

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

510(k) Number

K790432 ↗

FDA Product Code

DXY

Models / Variants

Microlith Models 505

605

507

607

703

803

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Acuity Universal Cutter

  Class II

  FDA 510(k) K080154 Active Cleared 20 Mar 2008

• Pacemaker Programmer #2010

  Class III

  FDA 510(k) K811217 Active Cleared 20 Jul 1981

• Microthin-Pii Bipolar Pulse Gen. #0623

  Class III

  FDA 510(k) K803034 Active Cleared 22 Dec 1980

• Astra 2, 3, 4 and 6: Chip Revision

  Not classified

  FDA 510(k) K863000 Active Cleared 19 Aug 1986

• Command Ultra I Implantable Pacemaker Pulse-Generator

  Class III

  FDA 510(k) K831161 Active Cleared 15 Jun 1983

• Elgiloy Stylet

  Class II

  FDA 510(k) K770243 Active Cleared 14 Feb 1977

See all devices from Cardiac Pacemakers, Inc. →

• What are the primary clinical uses for the Microlith Models 505; 605; 507; 607; 703; 803 pacemaker pulse-generators?

  These devices are designed to regulate cardiac rhythm in patients with bradycardia (slow heart rate) or conduction disorders, delivering electrical impulses to stimulate the heart muscle and maintain consistent heart function. They are intended for surgical implantation and are specifically classified as implantable pacemaker pulse-generators.

• Are these pacemaker models intended for single-use or reusable applications, and how are they supplied?

  The Microlith Models 505; 605; 507; 607; 703; 803 are supplied sterile and intended for single-use only. This ensures patient safety and reduces the risk of infection or device failure associated with reuse, requiring specialized training for proper implantation and maintenance.

• What regulatory pathway was followed for FDA clearance of these pacemaker models, and how can I verify compliance?

  Each model received FDA 510(k) clearance under the traditional review pathway, with a decision date of March 20, 1979. Compliance is tracked via unique FEI numbers assigned to each variant (e.g., 3002807576, 2017865, etc.), and they adhere to regulation number 870.3610 for implantable pacemakers. These identifiers can be referenced in regulatory databases to confirm authorization.

• How do I determine which specific model (e.g., 505 vs. 605) is appropriate for a patient’s needs?

  The Microlith models differ by variant (e.g., 505, 605, 703), but the device data does not specify clinical distinctions between them. Selection should be based on clinical evaluation, patient-specific requirements, and consultation with a cardiologist or electrophysiologist. The manufacturer’s technical documentation or a medical device specialist can provide further guidance on compatibility with pacing leads or patient profiles.

• What storage requirements apply to these pacemaker pulse-generators before implantation?

  Since these devices are sterile upon supply, they must be stored in their original, unopened packaging to preserve sterility. The packaging should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the manufacturer’s instructions for storage duration and conditions to ensure device integrity before use.