510(k) K943803 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM
| Applicant | Janus Biomedical, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jan 30, 1996 |
| Received | Aug 4, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943803
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2011 | Maquet Inc. Maquet HL Console for Heart Lung Machine HL20
HL 20 4-pumps console base: P/N 917741
HL 20 5-pumps console base: P/N 917751
Intended for use as an extracorporeal circulation device for perfusion last Terminated |
DTQ | None listed |
| Aug 22, 2011 | Maquet Inc. Maquet HL Console for Heart Lung Machine HL20:
HL 20 4-pumps console base: P/N 917741
HL 20 5-pumps console base: P/N 917751
The HL 20 is indicated for use as an extracorporeal circulation device for Terminated |
DTQ | None listed |
| Feb 22, 2011 | Maquet Cardiovascular Us Sales, Llc Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20. Terminated |
DTQ | None listed |
| Nov 7, 2006 | MAQUET Inc. Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank Terminated |
DTQ | None listed |
| Nov 7, 2006 | MAQUET Inc. Jostra HL-20 Heart Lung Machine - guiding pins Terminated |
DTQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.