Insulative Coating for Card. Pulse Gen

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K810901 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

• Implantable Pulse Generator Pacemakers

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  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

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• What is the insulative coating used for in the cardiac pulse generator, and how does it contribute to the device’s function?

  The insulative coating is designed to protect the internal components of the implantable pacemaker pulse generator from electrical interference and corrosion. This ensures the device operates reliably within the cardiovascular system by maintaining proper pacing functionality over time. It acts as a barrier that safeguards critical electronics, which is essential for long-term performance in implanted applications.

• Is this coating supplied as a standalone product, or is it integrated into the pulse generator during manufacturing?

  The insulative coating is not sold separately but is an integral part of the pulse generator’s manufacturing process. It is applied during production to ensure the device meets reliability standards for sterile, implantable use in cardiac pacemaker systems. This means it is only available as part of a fully assembled pulse generator, not as an individual component.

• How should the pulse generator with this coating be stored and handled, given its sterile and implantable nature?

  Storage and handling follow standard sterile medical device protocols, as required for implantable devices. This includes maintaining sterile packaging, protecting from contamination, and adhering to manufacturer guidelines to preserve the coating’s integrity and the device’s functionality. Proper storage ensures the pulse generator remains safe for surgical implantation and reliable long-term use.

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

  The insulative coating for the cardiac pulse generator was cleared through the FDA’s 510(k) process under the Traditional review pathway, with a decision of Substantially Equivalent (SESE). The Cardiovascular (CV) advisory committee was involved in reviewing the submission, as the device falls under the classification of an Implantable Pacemaker Pulse-Generator (device code DXY). No third-party review was required for this clearance.