Pulse Generator, Model 171

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

510(k) Number

K782161 ↗

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 171, and how does it function in a patient’s body?

  The Pulse Generator, Model 171, is designed as an implantable component of cardiac pacemaker systems to regulate heart rhythm in patients with bradycardia or conduction disorders. It generates timed electrical impulses to stimulate the heart muscle, compensating for impaired or absent natural pacemaker function and ensuring proper cardiac pacing.

• Is the Pulse Generator, Model 171, intended for reuse, or is it meant to be implanted as a single-use device?

  The Pulse Generator, Model 171, is supplied sterile and intended for single-use implantation. However, specific reuse protocols may apply if authorized by the manufacturer, so it’s important to follow their guidelines to ensure safety and compliance.

• What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its use?

  The Pulse Generator, Model 171, was cleared through the FDA’s 510(k) process (K782161) under the Traditional clearance type, with a decision of Substantially Equivalent. This means the device was determined to be as safe and effective as a legally marketed predicate device, adhering to strict regulatory standards for implantable cardiac devices.

• How is the Pulse Generator, Model 171, classified under FDA regulations, and what does this classification imply?

  The Pulse Generator, Model 171, is classified as a Class III medical device under FDA regulations (870.3610), which is the highest risk classification. This classification implies that the device requires pre-market approval due to its critical role in regulating heart function, ensuring rigorous safety and efficacy standards are met before use.