SORIN C5 SYSTEM MODEL 58-00-00— 510(k) K093882

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

2009-12-18

Decision date

2010-01-15

Decision

Substantially Equivalent

Clearance type

Special

Location

North Attleboro, MA, US

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• 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

• 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

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 →

• Z-0856-2014 — S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.Class II·Terminated·Sorin Group Deutschland GmbH·20131204
• Z-0271-2013 — S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.Class II·Terminated·Sorin Group USA, Inc.·20120919
• Z-0272-2013 — S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.Class II·Terminated·Sorin Group USA, Inc.·20120919
• Z-0273-2013 — S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.Class II·Terminated·Sorin Group USA, Inc.·20120919
• Z-0274-2013 — S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.Class II·Terminated·Sorin Group USA, Inc.·20120919
• Z-0275-2013 — Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.Class II·Terminated·Sorin Group USA, Inc.·20120919

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093882.