510(k) K011838 ยท DWA Control, Pump Speed, Cardiopulmonary Bypass
CENTRIFUGAL PUMP
| Applicant | Stockert Instrumente GmbH, North Attleboro MA, US |
| Decision | Substantially Equivalent, Feb 5, 2002 |
| Received | Jun 12, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011838
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2019 | LivaNova Deutschland GmbH Control Panel REF - 60-02-50: LivaNova SCP Pump Control Panel S5/C5. REF 60-02-50, IPX2, RxOnly, UDI: 04033817900993 Terminated |
DWA | None listed |
| Aug 26, 2019 | LivaNova Deutschland GmbH Control Panel REF - 60-02-15: LivaNova SCP Pump Control Panel. REF 60-02-15, IPX2, RxOnly, UDI:
04033817900986 Terminated |
DWA | None listed |
| Oct 29, 2012 | Sorin Group USA, Inc. SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139.
The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively Terminated |
DWA | None listed |
| Oct 29, 2012 | Sorin Group USA, Inc. SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954.
The SCP is a cardiopulmonary bypass speed control device indicated for use ex Terminated |
DWA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.