Implantable Ventricular-Inhib. C.P. Gen

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

510(k) Number

K802028 ↗

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 for which patients is it intended?

  This device is an Implantable Ventricular-Inhibit Cardiac Pacemaker Pulse-Generator designed to regulate heart rhythm by delivering electrical impulses to the heart muscle. It is specifically intended for patients with bradycardia or conduction disorders where spontaneous heart contractions are insufficient. The device inhibits ventricular contractions to maintain proper cardiac pacing, ensuring consistent heart function in eligible patients.

• How is this device supplied and what handling precautions should be taken during surgery?

  This device is supplied as a reusable medical implant and requires sterile handling during surgical procedures. Since it is intended for implantation, it must be prepared and used in a sterile environment to prevent infection and ensure patient safety.

• Is this device single-use or reusable, and what does that mean for maintenance and replacement?

  This device is explicitly described as reusable, meaning it is intended to remain implanted in the patient long-term. However, like all implanted devices, it may require periodic battery replacement or adjustments over time, which should be performed by a qualified healthcare professional following manufacturer guidelines.

• What regulatory pathway was followed for this device’s approval, and what does that imply for its use?

  This device received FDA clearance through a 510(k) submission (K802028) with a Substantially Equivalent determination under Regulation 870.3610, classified under product code DXY. This means it was deemed comparable to a legally marketed predicate device and is approved for use in cardiovascular applications, specifically for surgical implantation in patients with bradycardia or conduction disorders.