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SARNES HELP

by 3M Health Care, Sarns

510(k) K772001

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK772001 Date2 Nov 1977ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
DTQ
Device Class
Class II
Regulation
21 CFR Part 870.4220
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 SARNES HELP is a console component of a heart‑lung machine used for cardiopulmonary bypass procedures. It functions as the control interface for the extracorporeal circulation system that supports patients during cardiac surgery.

The device is classified as a Class II medical device (product code DTQ) and received a traditional FDA 510(k) clearance (K772001) on 2 Nov 1977 under regulation 870.4220. It is marketed by 3M Health Care, Sarns in Mchenry, Illinois, United States, and is listed for cardiovascular applications.

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