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Pacemaker, Ovalith-D Cardiac

by Caratomic

510(k) K790566

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESP Substantially Equivalent — Postmarket Surveillance · Traditional NumberK790566 Date19 Mar 1979ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DXY
Device Class
Class III
Regulation
21 CFR Part 870.3610
Advisory Committee
Cardiovascular
FDA Decision
SESP Substantially Equivalent — Postmarket Surveillance

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Pacemaker, Ovalith-D Cardiac is an implantable pulse-generator designed to regulate heart rhythm by delivering electrical impulses to the heart muscle. Classified as an Implantable Pacemaker Pulse-Generator, it is intended for patients with bradycardia or other cardiac conduction disorders requiring chronic pacing support.

This device is supplied as a sterile, single-use implant intended for surgical implantation by qualified healthcare professionals. It is regulated under FDA 510(k) clearance (K790566) and falls under the classification of Class III (high-risk, life-sustaining) medical devices, governed by regulation 870.3610. Postmarket surveillance is required, as indicated by the SESP decision. The device is manufactured by Caratomic and carries the product code DXY.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of patients is this pacemaker designed to support, and how does it work?

    This device is specifically designed for patients with bradycardia or other cardiac conduction disorders that require chronic pacing support. It functions as an implantable pulse-generator, delivering regulated electrical impulses to the heart muscle to maintain a consistent and healthy heart rhythm.

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

    The Pacemaker, Ovalith-D Cardiac is supplied as a sterile, single-use device. It is intended for surgical implantation by qualified healthcare professionals and is not designed for reuse.

  • What regulatory pathway does this device follow, and what classification does it hold?

    This device follows the FDA 510(k) clearance pathway, with the clearance number K790566. It is classified as a Class III medical device under regulation 870.3610, which includes high-risk, life-sustaining devices like implantable pacemaker pulse-generators.

  • Who is the manufacturer of this pacemaker, and where is it based?

    The manufacturer of the Pacemaker, Ovalith-D Cardiac is Caratomic, based in Mchenry, Illinois (IL), United States.

  • What kind of postmarket surveillance is required for this device?

    Postmarket surveillance is required for this device, as indicated by the SESP (Special Emphasis Postmarket Surveillance) decision. This ensures ongoing monitoring and assessment of its performance and safety after it has been cleared for use.