Implantable Programmable Unipolar Card

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

510(k) Number

K792052 ↗

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

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• What is the primary purpose of this implantable device, and how does its unipolar design differ from other pacemakers?

  This device is an implantable pacemaker pulse-generator designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle, specifically for patients with bradycardia or conduction disorders. The unipolar configuration uses a single electrode, which simplifies surgical implantation while maintaining effectiveness for chronic cardiac support. This design contrasts with bipolar pacemakers, which use two electrodes, potentially offering different pacing stability or tissue interaction.

• Is this device intended for reuse, or is it meant to be implanted once and left in place permanently?

  The device is sterile and intended for single-use implantation, meaning it is surgically placed within the body and remains implanted permanently to provide continuous cardiac pacing. It is not designed for removal or reuse.

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

  This device was cleared through the FDA’s 510(k) pathway, specifically under a traditional review process. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, which evaluates pacemakers and related cardiovascular devices. The clearance (K792052) was granted in 1979, confirming its substantial equivalence to prior-generation devices.

• Are there any specific storage instructions provided for this device, or should it be handled under standard medical device precautions?

  The regulatory submission does not detail specific storage conditions for this device. However, as a sterile, implantable medical device, it should be stored according to general medical device guidelines—typically in a clean, dry environment protected from contamination until implantation. Always follow manufacturer-provided instructions if available.

• How does the device’s classification (Class III) impact its use or restrictions in clinical settings?

  As a Class III medical device, this pacemaker is subject to stringent FDA oversight due to its role in life-sustaining or supporting functions. While this does not impose additional clinical restrictions beyond standard pacemaker use, it ensures rigorous pre-market evaluation for safety and efficacy. Clinicians should adhere to established protocols for implantation, programming, and patient monitoring, as dictated by medical guidelines and the device’s labeled instructions.