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Sorin Pulse Generator Model Lit 214 H

by Bentley Laboratories, Inc.

510(k) K792565

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 NumberK792565 Date5 Feb 1980ClearedStatusActive

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  • Withdrawn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 Sorin Pulse Generator Model Lit 214 H is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate cardiac rhythm by delivering electrical impulses to the heart when spontaneous contractions are insufficient. It is intended for patients requiring temporary or permanent pacing support to maintain normal heart function.

This device is supplied sterile and intended for single-use implantation by a qualified healthcare professional in a clinical setting. It is regulated under FDA 510(k) clearance (K792565) and falls under the Implantable Pacemaker Pulse-Generator nomenclature (DXY), adhering to regulatory standards for cardiovascular devices. Storage and handling must comply with manufacturer guidelines to ensure sterility and functionality prior to use.

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