Implantable Programmable Cardiac Pulse Generators

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

510(k) Number

K871992 ↗

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 types of heart conditions is this implantable pulse generator designed to treat, and how does it work?

  This device is specifically designed to manage bradycardia, tachycardia, and other cardiac conduction disorders by delivering controlled electrical impulses to the heart muscle. It functions as an implantable pacemaker, regulating abnormal heart rhythms through chronic pacing support. The device is surgically implanted under the skin in the chest and continuously monitors and adjusts heart rate as needed.

• Are multiple model variants available, and if so, how do I identify which one is right for my patient?

  Yes, this device comes in multiple model variants, each corresponding to a unique registration number (e.g., 2017865, 3005334138, etc.). While the exact specifications for each variant are not detailed here, the product code (DXY) and regulatory classification (870.3610) indicate these are implantable programmable cardiac pulse generators for chronic pacing. Consult the manufacturer’s documentation or a cardiologist to select the appropriate model based on patient needs, pacing requirements, and compatibility.

• Is this device intended for single-use or can it be reused after implantation?

  This device is sterile and intended for single-use implantation only. It is not designed for reuse, and surgical implantation requires sterile conditions. Reuse could compromise patient safety and device efficacy, so adherence to single-use guidelines is mandatory.

• How is this device regulated in the U.S., and what does the FDA clearance (K871992) mean for its use?

  This device holds FDA 510(k) clearance (K871992), meaning it was determined to be substantially equivalent to a legally marketed predicate device under the Traditional 510(k) review pathway. The clearance confirms compliance with FDA cardiovascular device standards and ensures it meets safety and effectiveness requirements for implantable pacemaker pulse generators. The advisory committee (CV) and product code (DXY) further classify it under cardiovascular devices, but clearance does not imply indication—only that it follows regulatory pathways for chronic pacing applications.

• What storage or handling precautions should be taken before implantation?

  Since the device is sterile and single-use, it must be stored in its original packaging until implantation to maintain sterility. Avoid exposure to extreme temperatures, moisture, or physical damage. Follow the manufacturer’s instructions for unpacking and handling to prevent contamination, as compromised sterility could risk infection during surgery.