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Coratomic Model OVALITH-920BP

by Corptomic

510(k) K811768

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)SESE Substantially Equivalent · Traditional NumberK811768 Date20 Jul 1981ClearedStatusActive

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  • Withdrawn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
SESE Substantially Equivalent

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 Coratomic Model Ovalith-920BP is an implantable pacemaker pulse-generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart when native conduction fails. This device is classified as a Class III medical device under FDA regulations, reflecting its role in life-sustaining or life-supporting functions.

The Ovalith-920BP is intended for surgical implantation and is supplied sterile for single-use. It is regulated under FDA 510(k) clearance (K811768) and falls under the device classification DXY, with a regulatory number of 870.3610. Storage and handling must comply with sterile medical device protocols to ensure proper functionality and patient safety.

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 is the primary purpose of the Coratomic Model Ovalith-920BP and how does it function in the body?

    The Coratomic Model Ovalith-920BP is an implantable pacemaker pulse-generator designed to regulate cardiac rhythm by delivering controlled electrical impulses to the heart when the body’s natural conduction system fails. It is intended for patients experiencing bradycardia or other conduction disorders, ensuring consistent heartbeats to maintain proper cardiac function.

  • Is the Coratomic Model Ovalith-920BP intended for single-use or can it be reused after implantation?

    The device is supplied sterile and explicitly labeled for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility, functionality, and patient safety.

  • How should the Coratomic Model Ovalith-920BP be stored to maintain its integrity before use?

    Since the device is sterile and intended for surgical implantation, it must be stored according to sterile medical device protocols. This includes keeping it in its original packaging, protected from contamination, and adhering to manufacturer guidelines to preserve functionality and sterility until use.

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

    The Coratomic Model Ovalith-920BP received FDA clearance through a Traditional 510(k) process (K811768), with a decision code of SESE (Substantially Equivalent) under the Cardiovascular (CV) Advisory Committee. This means the FDA determined it is comparable to a legally marketed predicate device, ensuring it meets safety and effectiveness standards for implantable pacemaker pulse-generators.