Cardiac Pulse Generator Model 150L

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

510(k) Number

K772026 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

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• What is the primary clinical purpose of the Cardiac Pulse Generator, Model 150L, and how does it function in patients?

  The Cardiac Pulse Generator, Model 150L, is designed to regulate and maintain the heart’s rhythm in patients with bradycardia or other cardiac conduction disorders. It achieves this by generating and delivering electrical impulses to the heart, ensuring consistent cardiac pacing when the natural pacemaker fails. This helps maintain a stable heart rate and rhythm for patients who require artificial pacing.

• Is the Cardiac Pulse Generator, Model 150L, intended for single-use or reusable applications, and how is it supplied?

  The Cardiac Pulse Generator, Model 150L, is supplied sterile for single-use implantation only. This ensures safety and reliability during the procedure, as it is intended to be implanted permanently within the patient’s body.

• What regulatory pathway was followed for FDA clearance of this device, and which advisory committee reviewed it?

  The Cardiac Pulse Generator, Model 150L, received FDA clearance through a 510(k) submission under the Substantially Equivalent (SESE) determination, classified under 21 CFR 870.3610. It was reviewed by the Cardiovascular (CV) Advisory Committee in 1977, aligning with cardiovascular medical specialty standards.

• Does this device come in multiple sizes or models, and if so, how would a clinician determine the appropriate one for a patient?

  The provided data does not specify multiple sizes or models for the Model 150L itself, but it is classified as an Implantable Pacemaker Pulse-Generator under product code DXY. Selection would typically depend on clinical assessment, patient anatomy, and compatibility with the intended pacing requirements. Consulting manufacturer documentation or a cardiologist is recommended for precise sizing and model selection.