Dideco S.p.A.
Waltham, MA, US
Dideco S.P.A. appears in FDA device records in Waltham, MA. FDA records list 33 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 33
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 33 510(k) clearances for Dideco S.p.A. between 1995 and 2005. The busiest year on record is 2002, with 6. The most recent is 2005, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 2 |
| 1996 | 1 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 2 |
| 2000 | 4 |
| 2001 | 3 |
| 2002 | 6 |
| 2003 | 4 |
| 2004 | 3 |
| 2005 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K052717 | D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER | DTM | Substantially Equivalent | |
| K051232 | D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER | DTM | Substantially Equivalent | |
| K050890 | ECC.O SYSTEM | KFM | Substantially Equivalent | |
| K050447 | PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR | DTZ | Substantially Equivalent | |
| K043323 | D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR | DTZ | Substantially Equivalent | |
| K041061 | D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS | DTM | Substantially Equivalent | |
| K033323 | D 903 AVANT ADULT HOLLOW FIBER OXYGENATOR AND D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR WITH COATING | DTZ | Substantially Equivalent | |
| K033987 | D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS | DTM | Substantially Equivalent | |
| K033714 | MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING | DTN | Substantially Equivalent | |
| K032040 | IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR | KFM | Substantially Equivalent | |
| K031223 | SYNTHESIS MIMESYS ADULT MEMBRANE OXYGENATOR | DTZ | Substantially Equivalent | |
| K030154 | IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR | KFM | Substantially Equivalent | |
| K021732 | DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT | KDI | Substantially Equivalent | |
| K022450 | INTEGRATED UNIT: SYNTHESIS: ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDHSHELL VENOUS/CARDIOTOMY | DTZ | Substantially Equivalent | |
| K020647 | DIDECO ELECTA | CAC | Substantially Equivalent | |
| K020997 | APEX PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR | DTZ | Substantially Equivalent | |
| K020351 | D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR | DTZ | Substantially Equivalent | |
| K014080 | APEX ADULT HOLLOWE FIBER OXYGENATOR | DTZ | Substantially Equivalent | |
| K013915 | D902 PH.I.S.I.O OXYGENATOR; D920 PH.I.S.I.O RESERVOIR; DIDECO D736 PH.I.S.I.O FILTER | DTZ | Substantially Equivalent | |
| K004001 | MONOLYTH MIMESYS HOLLOW FIBER OXYGENATOR | DTZ | Substantially Equivalent | |
| K010478 | DIDECO D901 LILLIPUT HOLLOW FIBER OXYGENATOR WITH OR WITHOUT SOFT VENOUS RESERVOIR BAG, WITH BIOCOMPATABLE TREATMENT SUR | DTZ | Substantially Equivalent | |
| K001388 | DATA MASTER PERFUSION MONITORING SYSTEM | DRY | Substantially Equivalent | |
| K001602 | DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.) | DTN | Substantially Equivalent | |
| K001021 | LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902 | DTZ | Substantially Equivalent | |
| K991737 | LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR | DTZ | Substantially Equivalent | |
| K992599 | DIDECO ATS AUTOTRANSFUSION CARDIOTOMY RESERVOIR | DTN | Substantially Equivalent | |
| K984322 | DIDECO D920, LILLIPUT 1 TWIN RESERVOIR | DTP | Substantially Equivalent | |
| K982650 | AUTOLOGOUS BLOOD MANAGEMENT SYSTEM (ABMS) | CAC | Substantially Equivalent | |
| K980600 | D903 AVANT ADULT HOLLOW FIBER OXYGENATOR | JOW | Substantially Equivalent | |
| K971877 | LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR | DTZ | Substantially Equivalent | |
| K953835 | LILLIPUT 1 NEW BORN HOLLOW FIBER OXYGENATOR | DTZ | Substantially Equivalent | |
| K936220 | DIDECO VACUUM PUMP | CAC | Substantially Equivalent | |
| K940519 | DIDECO COMPACT-A AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CACApparatus, Autotransfusion
- DTPDefoamer, Cardiopulmonary Bypass
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
- DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- DTZOxygenator, Cardiopulmonary Bypass
- KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- DTNReservoir, Blood, Cardiopulmonary Bypass
- JOWSleeve, Limb, Compressible
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Dideco S.p.A. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Dideco S.p.A.. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.
Data as of , FDA export datePage updated Source: openFDA, public domain