510(k) K071318 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
MODIFICATION TO: STOCKERT S5 SYSTEM
| Applicant | Sorin Group Deutschland GmbH, North Attleboro MA, US |
| Decision | Substantially Equivalent, Jul 6, 2007 |
| Received | May 10, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071318
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2019 | LivaNova USA Inc. LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594
Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulat Terminated |
DTQ | None listed |
| Sep 21, 2016 | Sorin Group USA, Inc. Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console
Product Usage:
The Stckert S5 System is intended to be used during cardiopulmonary bypass for procedures la Terminated |
DTQ | None listed |
| Jan 28, 2014 | Sorin Group Deutschland GmbH 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. Terminated |
DTQ | None listed |
| Nov 4, 2013 | Sorin Group Deutschland GmbH S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00.
The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less. Terminated |
DTQ | None listed |
| Nov 8, 2012 | Sorin Group USA, Inc. 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. Terminated |
DTQ | None listed |
| Nov 8, 2012 | Sorin Group USA, Inc. 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. Terminated |
DTQ | None listed |
| Nov 8, 2012 | Sorin Group USA, Inc. 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. Terminated |
DTQ | None listed |
| Nov 8, 2012 | Sorin Group USA, Inc. 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. Terminated |
DTQ | None listed |
| Nov 8, 2012 | Sorin Group USA, Inc. 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. Terminated |
DTQ | None listed |
| Mar 29, 2012 | Sorin Group Deutschland GmbH S5 Single Roller Pump 150
The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. Terminated |
DTQ | None listed |
| Mar 29, 2012 | Sorin Group Deutschland GmbH S5 Double Roller Pump 85
The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. Terminated |
DTQ | None listed |
| Mar 29, 2012 | Sorin Group Deutschland GmbH Control panel for mast roller pump 150/85
The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. Terminated |
DTQ | None listed |
| Mar 29, 2012 | Sorin Group Deutschland GmbH Control panel for mast roller pump 85
The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. Terminated |
DTQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.