Impl. Programmable Bipolar CARD.GEN.#274

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

510(k) Number

K803197 ↗

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 implantable device and how does its programmable bipolar system work?

  This device is an implantable pacemaker pulse-generator designed to regulate abnormal cardiac rhythms by delivering controlled electrical impulses to the heart. The programmable bipolar system allows clinicians to adjust pacing parameters—such as pulse amplitude, rate, and timing—via external programming tools, ensuring tailored support for patients with bradycardia or other conduction disorders. The bipolar configuration minimizes current dispersion, improving efficiency and reducing potential tissue irritation.

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

  This device is not intended for single-use and is explicitly described as a reusable medical implant. It is designed for surgical implantation within the body and remains functional for long-term cardiac support, though it may require periodic replacement due to battery depletion or other clinical factors. Reuse is limited to its original intended purpose as a pacemaker pulse-generator.

• What regulatory pathway was followed for FDA clearance, and what does the classification mean for clinicians?

  This device received FDA 510(k) clearance under the traditional pathway in 1981, with a substantially equivalent (SE) determination by the Cardiovascular (CV) Advisory Committee. It falls under FDA regulation number 870.3610 and is classified as a Class III device, meaning it carries higher risk and requires stringent premarket approval processes. Clinicians should note that this classification reflects its role in life-sustaining or supporting functions, necessitating careful patient selection and post-implantation monitoring.

• Are there any specific storage requirements or handling instructions provided for this device?

  The provided data does not specify sterility or detailed storage instructions for this implantable device. As a reusable medical implant, it should be handled in accordance with standard sterile surgical protocols prior to implantation. Post-implantation, storage would follow typical guidelines for pacemaker pulse-generators, including protection from electromagnetic interference and environmental contaminants. Always refer to the manufacturer’s updated instructions for handling and storage.