Dideco S.P.A.
Medical device manufacturer in Waltham, MA.
22510(k) clearances
0PMA approvals
0recalls
Device types
- DTZ Oxygenator, Cardiopulmonary Bypass 10
- DTN Reservoir, Blood, Cardiopulmonary Bypass 3
- CAC Apparatus, Autotransfusion 2
- KFM Pump, Blood, Cardiopulmonary Bypass… 2
- DTM Filter, Blood, Cardiopulmonary Bypass… 2
- JOW Sleeve, Limb, Compressible 1
- DTP Defoamer, Cardiopulmonary Bypass 1
- KDI Dialyzer, High Permeability With Or Without… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K041061 | D731 Micro 20 and D733 Micro 40 Pediatric Arterial FiltersDTM · Special | 05/06/2004SE |
| K033323 | D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 Ph.I.S.I.O. Adult Hollow…DTZ · Abbreviated | 01/13/2004SE |
| K033987 | D735 Micro 20 and D736 Micro 40 Newborn-Infant Arterial FiltersDTM · Special | 01/08/2004SE |
| K033714 | MVR 1200 PC: Sorin Monolyth Venous Reservoir 1200 PC with Phosphorylcholine CoatingDTN · Special | 12/11/2003SE |
| K032040 | Ideal Mimesys System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump…KFM · Special | 07/09/2003SE |
| K031223 | Synthesis Mimesys Adult Membrane OxygenatorDTZ · Special | 05/02/2003SE |
| K030154 | Ideal: System with Integrated Venous Air Removal, Centrifugal Blood Pump, Pump Bracket…KFM · Abbreviated | 03/31/2003SE |
| K021732 | DHF 0.2 Hemoconcentrator: Dideco Newborn-Infant Hemoncentration; DHR 0.6…KDI · Traditional | 11/04/2002SE |
| K022450 | Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter…DTZ · Abbreviated | 10/22/2002SE |
| K020647 | Dideco ElectaCAC · Abbreviated | 09/05/2002SE |
| K020997 | Apex Ph.I.S.I.O. Adult Hollow Fiber Membrane OxygenatorDTZ · Special | 04/04/2002SE |
| K020351 | D 903 Avant 2 Ph.I.S.I.O. Adult Hollow Fiber OxygenatorDTZ · Special | 02/26/2002SE |
| K014080 | Apex Adult Hollowe Fiber OxygenatorDTZ · Special | 01/08/2002SE |
| K013915 | D902 Ph.I.S.I.O Oxygenator; D920 Ph.I.S.I.O Reservoir; Dideco D736 Ph.I.S.I.O FilterDTZ · Special | 12/27/2001SE |
| K001602 | Dideco Lilliput 1 Twin Reservoir with Phosphorilcholine Insert Surface in Oxygenation…DTN · Special | 06/08/2000SE |
| K001021 | Lilliput Phospholypidic Inert Surface in Oxygenation (Ph.I.S.I.O.) Infant Hollow Fibre…DTZ · Special | 04/25/2000SE |
| K991737 | Lilliput Phospholypidic Inert Surface in Oxygenation (Ph.I.S.I.O.) Infant/Newborn Hollow…DTZ · Traditional | 02/17/2000SE |
| K992599 | Dideco Ats Autotransfusion Cardiotomy ReservoirDTN · Abbreviated | 11/01/1999SE |
| K984322 | Dideco D920, Lilliput 1 Twin ReservoirDTP · Traditional | 03/02/1999SE |
| K982650 | Autologous Blood Management System (Abms)CAC · Abbreviated | 12/16/1998SE |
| K980600 | D903 Avant Adult Hollow Fiber OxygenatorJOW · Traditional | 08/12/1998SE |
| K971877 | Lilliput 2 Infant Hollow Fiber OxygenatorDTZ · Traditional | 10/08/1997SE |