Implantable Ventricular-Inhibited Cardi

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

510(k) Number

K812790 ↗

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 ventricular-inhibited cardiac device, and how does it function in the body?

  This device is an implantable pacemaker pulse-generator designed to regulate heart rhythm by delivering electrical impulses to the heart muscle. Specifically, it uses ventricular inhibition to prevent rapid or irregular heartbeats when the body’s natural pacemaker fails, ensuring stable cardiac function.

• Is this device intended for reuse, or is it meant to be used only once after implantation?

  The device is supplied as a single-use, sterile unit, meaning it is not designed for reuse. Once implanted, it should not be removed or reused for another patient, adhering to standard sterile medical device protocols.

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

  This device received FDA 510(k) clearance under the Traditional review pathway with a Substantially Equivalent (SESE) determination. The Cardiovascular (CV) Advisory Committee reviewed and approved its classification as an Implantable Pacemaker Pulse-Generator.

• How should this device be stored to maintain sterility before implantation?

  Since it is a sterile, single-use device, storage must comply with strict sterile medical device protocols. This includes keeping it in its original packaging, protected from contamination, and following manufacturer guidelines to preserve integrity until use.

• Does this device have any known MRI safety classification, or should patients avoid MRI scans after implantation?

  The provided data does not specify an MRI safety classification for this device. Patients should consult the manufacturer’s instructions or a healthcare provider before undergoing MRI scans to assess potential risks.