Company ยท US
Dideco S.P.A.
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2004. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | 12 |
| CAC | Apparatus, Autotransfusion | 4 |
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | 3 |
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 2 |
| KFM | Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type | 2 |
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | 1 |
| DTP | Defoamer, Cardiopulmonary Bypass | 1 |
| JOW | Sleeve, Limb, Compressible | 1 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 6, 2004 | K041061 | D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS Dideco S.P.A. | DTM |
| Jan 13, 2004 | K033323 | D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING Dideco S.P.A. | DTZ |
| Jan 8, 2004 | K033987 | D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS Dideco S.P.A. | DTM |
| Dec 11, 2003 | K033714 | MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING Dideco S.P.A. | DTN |
| Jul 9, 2003 | K032040 | IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR Dideco S.P.A. | KFM |
| May 2, 2003 | K031223 | SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR Dideco S.P.A. | DTZ |
| Mar 31, 2003 | K030154 | IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR Dideco S.P.A. | KFM |
| Nov 4, 2002 | K021732 | DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT Dideco S.P.A. | KDI |
| Oct 22, 2002 | K022450 | INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY Dideco S.P.A. | DTZ |
| Sep 5, 2002 | K020647 | DIDECO ELECTA Dideco S.P.A. | CAC |
| Apr 4, 2002 | K020997 | APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR Dideco S.P.A. | DTZ |
| Feb 26, 2002 | K020351 | D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR Dideco S.P.A. | DTZ |
| Jan 8, 2002 | K014080 | APEX ADULT HOLLOWE FIBER OXYGENATOR Dideco S.P.A. | DTZ |
| Dec 27, 2001 | K013915 | D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER Dideco S.P.A. | DTZ |
| Oct 4, 2001 | K004001 | MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR Dideco | DTZ |
| Sep 27, 2001 | K010478 | DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR Dideco | DTZ |
| Jul 28, 2000 | K001388 | DATA MASTER PERFUSION MONITORING SYSTEM Dideco | DRY |
| Jun 8, 2000 | K001602 | DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.) Dideco S.P.A. | DTN |
| Apr 25, 2000 | K001021 | LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902 Dideco S.P.A. | DTZ |
| Feb 17, 2000 | K991737 | LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR Dideco S.P.A. | DTZ |
| Nov 1, 1999 | K992599 | DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR Dideco S.P.A. | DTN |
| Mar 2, 1999 | K984322 | DIDECO D920, LILLIPUT 1 TWIN RESERVOIR Dideco S.P.A. | DTP |
| Dec 16, 1998 | K982650 | AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) Dideco S.P.A. | CAC |
| Aug 12, 1998 | K980600 | D903 AVANT ADULT HOLLOW FIBER OXYGENATOR Dideco S.P.A. | JOW |
| Oct 8, 1997 | K971877 | LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR Dideco S.P.A. | DTZ |
| Jan 27, 1995 | K936220 | DIDECO VACUUM PUMP Dideco, IT | CAC |
| Jan 19, 1995 | K940519 | DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM Dideco | CAC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||