Dideco D920, Lilliput 1 Twin Reservoir
FDA 510(k) K984322 · Dideco S.P.A.
510(k) numberK984322
Submission
- Device name
- Dideco D920, Lilliput 1 Twin Reservoir
- Applicant
- Dideco S.P.A.
Waltham, MA, US - Received
- December 3, 1998
- Decision date
- March 2, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTP – Defoamer, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4230
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K101186 | Affinity Vard Sub-Assembly for CPS (Carmeda Coated), Purgeline (Uncoated), Holding BagDTP · Traditional | Medtronic Perfusion Systems | 09/03/2010SE |
| K082412 | Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model Be-Vbt…DTP · Traditional | Mapquet Cardiopulmonary AG | 11/10/2008SE |
| K004046 | Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000 Filtered…DTP · Traditional | Cobe Cardiovascular, Inc. | 04/26/2001SE |
| K002591 | Cobe Smarxt VVR 4000 Filtered Hardshell Venous ReservoirDTP · Special | Cobe Cardiovascular, Inc. | 09/13/2000SE |
| K990514 | Modification of Bard Quantum CVR, Model H-6770VRDTP · Special | C.R. Bard, Inc. | 03/09/1999SE |
| K962726 | Bard Quantum CVRDTP · Traditional | C.R. Bard, Inc. | 10/30/1996SE |
| K941654 | Sarns Filtered Venous Reservior ModificationDTP · Traditional | 3M Health Care, Sarns | 07/26/1994SE |
| K933496 | Maxima Filtered Hardshell ReserviorDTP · Traditional | Medtronic Vascular | 10/15/1993SE |
| K912915 | Sarns Non-Filtered Venous ReservoirDTP · Traditional | 3M Health Care, Ltd. | 09/25/1991SE |
| K911789 | Minimax (TM) Hardshell Venous Res W/Inte Card FiltDTP · Traditional | Medtronic Vascular | 08/20/1991SE |
More from Medtronic Vascular
| 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 |
Questions and answers
When was Dideco D920, Lilliput 1 Twin Reservoir cleared by the FDA?
Dideco D920, Lilliput 1 Twin Reservoir (K984322) received a 510(k) decision of Substantially Equivalent on March 2, 1999, 89 days after the submission was received.
What is the product code of K984322?
The FDA product code is DTP – Defoamer, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4230.