Implantable Bipolar Cardiac Pulse Gen

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

510(k) Number

K833427 ↗

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 this device, and how does it function in the body?

  This device is an implantable bipolar cardiac pulse generator designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. It is specifically intended for patients with bradycardia (slow heart rate) or conduction disorders, stimulating the heart to maintain proper pacing and rhythm. The device is implanted within the body and works continuously to ensure consistent cardiac function.

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

  The device is sterile and supplied for single-patient use only, meaning it is not designed for reuse. Once implanted, it remains in the patient’s body as a permanent solution. Sterility protocols must be followed during handling and implantation to ensure patient safety.

• How many model configurations are available, and how can I identify the correct one for my patient?

  This device comes in multiple model configurations, each identified by a unique FEI (Facility Establishment Identifier) number. There are 18 distinct FEI numbers listed for this product, such as 3002807576, 2017865, and others. The correct model should be selected based on clinical needs, compatibility with leads, and manufacturer specifications—consult the device documentation or your supplier for guidance.

• What storage conditions should be followed for this device before implantation?

  Since this is a sterile, implantable medical device, it must be stored in accordance with sterile medical device protocols. This typically includes keeping it in its original, unopened packaging in a clean, dry environment, protected from moisture, extreme temperatures, and physical damage. Always refer to the manufacturer’s instructions for precise storage guidelines.

• How was this device’s regulatory pathway determined, and what does that mean for its use?

  This device was classified as Class III under FDA regulations and required a 510(k) clearance (K833427) through the Traditional 510(k) review pathway. The decision was based on its role in regulating life-sustaining cardiac function, requiring rigorous pre-market evaluation. The Cardiovascular (CV) Advisory Committee provided guidance during the review process, ensuring its safety and effectiveness before approval for commercial distribution.