Implantable Bipolar Cardiac Pulse Gen.

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

510(k) Number

K800030 ↗

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 device designed to address, and how does it work?

  This Implantable Bipolar Cardiac Pulse Generator is specifically designed to manage bradycardia (slow heart rate) and other cardiac conduction disorders that require chronic pacing support. It achieves this by delivering precise electrical impulses to the heart muscle, helping to regulate abnormal heart rhythms. The device can function as a standalone unit or as part of a larger pacing system when paired with appropriate leads.

• Is this device intended for reuse, or is it meant to be implanted as a single-use device?

  The device is sterile upon supply and intended for single-use implantation. While the manufacturer does not explicitly endorse reuse, if sterile conditions are maintained, specific reuse protocols *may* apply under controlled circumstances. However, adherence to sterile medical device protocols is mandatory to ensure patient safety.

• What storage and handling requirements must be followed for this device?

  Since this is a sterile medical device, storage and handling must comply with standard sterile medical device protocols to prevent contamination. The device should be stored in its original packaging until implantation, and any exposure to non-sterile environments should be minimized to maintain integrity.

• How is this device regulated, and what regulatory body oversees its approval process?

  This device is classified as a Class III medical device under FDA regulations and has received 510(k) clearance (K800030). The approval process involved submission to the FDA’s Cardiovascular (CV) Advisory Committee, with the device falling under the Implantable Pacemaker Pulse-Generator (product code DXY) category. Its use is governed by FDA regulation number 870.3610.

• Does this device come in multiple sizes or models, and if so, how would I determine the appropriate one for a patient?

  The provided data does not specify distinct sizes or models for this device, but it is designed as a bipolar cardiac pulse generator, meaning it is likely engineered to interface with various lead systems for pacing. Selection should be based on clinical need, patient anatomy, and compatibility with the intended pacing system, ideally guided by a cardiologist or electrophysiologist.