Medical Device Manufacturer · US , Waltham , MA

Dideco S.P.A. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 1997
22
Total
22
Cleared
0
Denied
FDA 510(k) Regulatory Record - Dideco S.P.A. Cardiovascular
19 devices
1-19 of 19
Cleared May 06, 2004
D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS
K041061 · DTM
Cardiovascular · 13d
Cleared Jan 13, 2004
D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT...
K033323 · DTZ
Cardiovascular · 90d
Cleared Jan 08, 2004
D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS
K033987 · DTM
Cardiovascular · 16d
Cleared Dec 11, 2003
MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE...
K033714 · DTN
Cardiovascular · 15d
Cleared Jul 09, 2003
IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD...
K032040 · KFM
Cardiovascular · 8d
Cleared May 02, 2003
SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR
K031223 · DTZ
Cardiovascular · 14d
Cleared Mar 31, 2003
IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP,...
K030154 · KFM
Cardiovascular · 74d
Cleared Oct 22, 2002
INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED...
K022450 · DTZ
Cardiovascular · 88d
Cleared Apr 04, 2002
APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K020997 · DTZ
Cardiovascular · 7d
Cleared Feb 26, 2002
D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR
K020351 · DTZ
Cardiovascular · 22d
Cleared Jan 08, 2002
APEX ADULT HOLLOWE FIBER OXYGENATOR
K014080 · DTZ
Cardiovascular · 28d
Cleared Dec 27, 2001
D902 PH.I.S.I.O OXYGENATOR
K013915 · DTZ
Cardiovascular · 30d
Cleared Jun 08, 2000
DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN...
K001602 · DTN
Cardiovascular · 15d
Cleared Apr 25, 2000
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT...
K001021 · DTZ
Cardiovascular · 26d
Cleared Feb 17, 2000
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.)...
K991737 · DTZ
Cardiovascular · 272d
Cleared Nov 01, 1999
DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K992599 · DTN
Cardiovascular · 90d
Cleared Mar 02, 1999
DIDECO D920, LILLIPUT 1 TWIN RESERVOIR
K984322 · DTP
Cardiovascular · 89d
Cleared Aug 12, 1998
D903 AVANT ADULT HOLLOW FIBER OXYGENATOR
K980600 · JOW
Cardiovascular · 176d
Cleared Oct 08, 1997
LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR
K971877 · DTZ
Cardiovascular · 140d
Filters