Pulse Generator Model 160B

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

Full name

Generator, Pulse, Model 160B

510(k) Number

K780940 ↗

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

See all devices from Telectronics, Inc. →

• What is the primary purpose of the Pulse Generator Model 160B and how does it function in patients?

  The Pulse Generator Model 160B is an implantable pacemaker designed to deliver electrical impulses to regulate heart rhythm in patients with bradycardia or cardiac conduction disorders. It maintains proper cardiac function by providing consistent pacing signals, ensuring the heart beats at a stable rate when its natural electrical system is impaired.

• Is the Pulse Generator Model 160B intended for reuse or is it single-use only?

  The Pulse Generator Model 160B is supplied sterile and intended for single-use only. This is explicitly stated in the device description, requiring adherence to sterile medical device protocols during storage and handling to ensure patient safety.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Pulse Generator Model 160B received FDA 510(k) clearance (K780940) under the traditional review pathway, determined to be substantially equivalent to predicate devices. It is classified as a Class III medical device under regulation 870.3610, reflecting its critical role in life-sustaining or supporting functions.

• How should the Pulse Generator Model 160B be stored and handled to maintain sterility?

  Since the device is sterile upon supply and intended for single-use, storage and handling must comply with standard sterile medical device protocols. This includes protecting it from contamination, moisture, and physical damage until implantation by qualified healthcare professionals.