Implantable Ventricular-Inhibited

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

510(k) Number

K791727 ↗

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 the Implantable Ventricular-Inhibited Cardi device, and how does it differ from other pacemakers?

  The Implantable Ventricular-Inhibited Cardi is designed as an Implantable Pacemaker Pulse-Generator to regulate heart rhythm by delivering electrical impulses to the heart muscle. Its key feature is ventricular inhibition, meaning it only provides pacing stimuli when the heart’s natural electrical activity is absent or insufficient. This distinguishes it from non-inhibited pacemakers by ensuring pacing occurs only when needed, helping maintain proper cardiac rhythm in patients with bradycardia or conduction disorders.

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

  The device is supplied sterile for single-patient application, meaning it is intended to be used once per patient and not reused. This ensures patient safety and sterility, as it requires professional implantation in a controlled clinical setting.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Implantable Ventricular-Inhibited Cardi received FDA clearance through the Traditional 510(k) pathway, specifically under regulation number 870.3610 for pacemaker pulse-generators. This means the manufacturer demonstrated that the device is substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed in the U.S. for its intended use in regulating heart rhythm.

• Can this device be used in patients who require MRI scans, or are there any restrictions?

  The regulatory data does not specify MRI compatibility for this device, so it is not recommended for use in patients who require MRI scans unless explicitly confirmed by the manufacturer. Always verify compatibility with the device manufacturer before exposing the patient to MRI environments.

• How is the device packaged and stored, and what are the implications for handling?

  The device is supplied sterile in packaging designed for single-patient use. This means it must be handled with care to maintain sterility until implantation, and it should only be opened and used by trained healthcare professionals in a controlled clinical setting. Improper handling could compromise sterility and patient safety.