STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER— 510(k) K080832

Name: FDA 510(k) clearance K080832
Creator: U.S. Food and Drug Administration
Published: 2008-07-30

Substantially Equivalent

Sorin Group Deutschland GmbH

FDA 510(k) clearance K080832 for STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER, Substantially Equivalent on 2008-07-30. Applicant: Sorin Group Deutschland GmbH. Device class: 2.

Clearance details

Applicant: Sorin Group Deutschland GmbH
Product code: Code DTQ
Device class: Class 2
Regulation: 21 CFR 870.4220
Advisory panel: Cardiovascular
Date received: 2008-03-25
Decision date: 2008-07-30
Decision: Substantially Equivalent
Clearance type: Special
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTQ

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K232291 — Essenz HLM, Essenz ILBM2023-08-24
K221895 — Terumo Advanced Perfusion System 12023-04-18
K221373 — Essenz HLM2023-03-09
K210130 — Stockert S5 System2021-04-05
K202125 — Century Perfusion System2021-03-07

More clearances from Sorin Group Deutschland GmbH

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K170460 — Sorin Connect2017-06-08
K131553 — XTRA2014-03-21
K140012 — SORIN FLEXTHERM2014-01-31
K131816 — SORIN CONNECT DATA MANAGEMENT SYSTEM2013-07-23
K112225 — SORIN CENTRIFUGAL PUMP 5 (CP5)2011-09-20

Adverse events under product code DTQ

product code DTQ

Death: 123
Malfunction: 4,822
Other: 1
Total: 4,946

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.