Medical Device Manufacturer · US , Waltham , MA

Dideco S.P.A.

22 submissions · 22 cleared · Since 1997
22
Total
22
Cleared
0
Denied

Dideco S.P.A. — FDA 510(k) Submissions

Dideco S.P.A. has submitted 22 FDA 510(k) premarket notifications since 1997, of which 22 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Oxygenator, Cardiopulmonary Bypass, Reservoir, Blood, Cardiopulmonary Bypass, Pump, Blood, Cardiopulmonary Bypass, Non-roller Type, Filter, Blood, Cardiopulmonary Bypass, Arterial Line, Apparatus, Autotransfusion . Use the specialty filter in the sidebar to narrow results.

22 devices
1–22 of 22
D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS
K041061 · DTM Filter, Blood,... · Cardiovascular
May 2004 13d
D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING
K033323 · DTZ Oxygenator,... · Cardiovascular
Jan 2004 90d
D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS
K033987 · DTM Filter, Blood,... · Cardiovascular
Jan 2004 16d
MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING
K033714 · DTN Reservoir, Blood,... · Cardiovascular
Dec 2003 15d
IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
K032040 · KFM Pump, Blood,... · Cardiovascular
Jul 2003 8d
SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR
K031223 · DTZ Oxygenator,... · Cardiovascular
May 2003 14d
IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
K030154 · KFM Pump, Blood,... · Cardiovascular
Mar 2003 74d
DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT
K021732 · KDI Dialyzer, High... · Gastroenterology & Urology
Nov 2002 164d
INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY
K022450 · DTZ Oxygenator,... · Cardiovascular
Oct 2002 88d
DIDECO ELECTA
K020647 · CAC Apparatus, Autotransfusion · Anesthesiology
Sep 2002 189d
APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
K020997 · DTZ Oxygenator,... · Cardiovascular
Apr 2002 7d
D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR
K020351 · DTZ Oxygenator,... · Cardiovascular
Feb 2002 22d
APEX ADULT HOLLOWE FIBER OXYGENATOR
K014080 · DTZ Oxygenator,... · Cardiovascular
Jan 2002 28d
D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER
K013915 · DTZ Oxygenator,... · Cardiovascular
Dec 2001 30d
DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)
K001602 · DTN Reservoir, Blood,... · Cardiovascular
Jun 2000 15d
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902
K001021 · DTZ Oxygenator,... · Cardiovascular
Apr 2000 26d
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR
K991737 · DTZ Oxygenator,... · Cardiovascular
Feb 2000 272d
DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K992599 · DTN Reservoir, Blood,... · Cardiovascular
Nov 1999 90d
DIDECO D920, LILLIPUT 1 TWIN RESERVOIR
K984322 · DTP Defoamer, Cardiopulmonary... · Cardiovascular
Mar 1999 89d
AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS)
K982650 · CAC Apparatus, Autotransfusion · Anesthesiology
Dec 1998 139d
D903 AVANT ADULT HOLLOW FIBER OXYGENATOR
K980600 · JOW Sleeve, Limb, Compressible · Cardiovascular
Aug 1998 176d
LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR
K971877 · DTZ Oxygenator,... · Cardiovascular
Oct 1997 140d
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