Skip to content

Multicor S, Models 330A/331A

by Cordis Corp.

510(k) K851420

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 NumberK851420 Date21 Jun 1985ClearedStatusActive

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  • Withdrawn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 Multicor S, Models 330A/331A, is an implantable pacemaker pulse-generator designed to regulate cardiac rhythm by delivering electrical impulses to the heart. This device is classified as a Class III medical device under FDA regulations, intended for patients requiring chronic cardiac pacing to manage bradycardia or other conduction disorders.

These models are supplied sterile and intended for single-use implantation by qualified healthcare professionals in clinical settings. The devices are regulated under FDA 510(k) clearance (K851420) and fall under the product code DXY, adhering to the requirements of regulation number 870.3610. Storage and handling must comply with sterile medical device protocols to ensure patient safety and device efficacy.

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →

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 Multicor S, Models 330A/331A, and who should use it?

    The Multicor S, Models 330A/331A, is designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for patients who require chronic cardiac pacing due to bradycardia or other conduction disorders, ensuring consistent heartbeats for stable cardiac function.

  • Are the Multicor S devices sterile and meant for single-use, or can they be reused?

    Yes, the Multicor S, Models 330A/331A, are supplied sterile and explicitly intended for single-use implantation only. Reuse is not recommended, as this could compromise sterility and patient safety.

  • How should the Multicor S devices be stored to maintain their integrity?

    The devices must be stored and handled according to sterile medical device protocols to preserve efficacy and ensure patient safety. Proper storage conditions are critical, as they are implanted directly into the body.

  • What regulatory pathway was followed for FDA clearance of the Multicor S, and what does this mean for clinicians?

    The Multicor S, Models 330A/331A, received FDA 510(k) clearance (K851420) under the traditional review process, with a decision of *Substantially Equivalent* to a predicate device. This means the device meets FDA standards for safety and effectiveness as an implantable pacemaker pulse-generator, ensuring it adheres to regulatory requirements for chronic cardiac pacing.