Implantable Cardiac Pacemaker

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

Full name

Implantable Program. Cardiac Pacemaker

510(k) Number

K800793 ↗

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 clinical purpose of this implantable cardiac pacemaker, and how does it function in patients?

  This device is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when the natural pacemaker fails to maintain an adequate rate or rhythm. It is specifically intended for patients with bradycardia (slow heart rate) or conduction disorders, helping to support cardiac function by ensuring the heart beats at a consistent and appropriate rate.

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

  The device is supplied sterile and explicitly intended for single-use only. Once implanted, it is not designed or approved for removal and reuse, adhering to standard medical device practices for implantable cardiac devices.

• What regulatory pathway was followed for this device’s FDA clearance, and which advisory committee was involved?

  This pacemaker received FDA clearance through a Traditional 510(k) pathway, determined to be Substantially Equivalent to a predicate device. The clearance was reviewed by the FDA’s Cardiovascular (CV) Advisory Committee and falls under the classification of Class III medical devices (product code DXY). The decision was finalized on September 18, 1980.

• How should this device be stored before implantation, and what are the key handling considerations?

  Since the device is supplied sterile, it must be stored in its original packaging until use to maintain sterility. Proper storage includes keeping it in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain unopened until immediately before implantation to prevent contamination.

• Does this pacemaker come in multiple models or sizes, and if so, how are they differentiated?

  The data provided lists multiple FEI numbers (e.g., 3002807576, 2017865), which typically correspond to distinct models or variants of the device. While specific size or model details (e.g., battery life, lead configurations) are not explicitly described here, these identifiers suggest the device may offer different configurations or iterations for clinical customization. For precise sizing or model specifications, refer to the manufacturer’s technical documentation or catalog.