Dideco Lilliput 1 Twin Reservoir with Phosphorilcholine Insert Surface in Oxygenation (Ph. I.S.I.O.)
FDA 510(k) K001602 · Dideco S.P.A.
510(k) numberK001602
Submission
- Device name
- Dideco Lilliput 1 Twin Reservoir with Phosphorilcholine Insert Surface in Oxygenation (Ph. I.S.I.O.)
- Applicant
- Dideco S.P.A.
Waltham, MA, US - Received
- May 24, 2000
- Decision date
- June 8, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DTN – Reservoir, Blood, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4400
- Specialty
- Cardiovascular
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| K241206 | Quantum Perfusion Hybrid SystemDTN · Traditional | Spectrum Medical S.R.L. | 07/18/2024SE |
| K241053 | MVR Venous Reservoir Bag 800 mL; MVR Venous Reservoir Bag 1600 mL; MVR Venous…DTN · Special | Medtronic Cardiac Surgery | 05/15/2024SE |
| K223361 | BMR 1900 PhisioDTN · Traditional | Sorin Group Italia S.R.L. | 06/10/2023SE |
| K170583 | Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive SurfaceDTN · Special | Medtronic, Inc. | 03/17/2017SE |
| K161733 | Inspire SVR 1200, Inspire 6F C, Inspire 8F CDTN · Traditional | Sorin Group Italia S.R.L. | 03/08/2017SE |
| K153143 | Capiox Advance Hardshell ReservoirDTN · Special | Terumo Cardiovascular Systems Corporation | 12/02/2015SE |
| K151110 | Intersept Filtered Cardiotomy ReservoirDTN · Special | Medtronic, Inc. | 05/27/2015SE |
| K141432 | Neonatal Venous Hardshell Cardiotomy Reservior, Pediatric Venous Hardshell Cardiotomy…DTN · Special | Maquet Cardiopulmonary, AG | 07/07/2014SE |
| K141233 | Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance BiosufaceDTN · Special | Medtronic, Inc. | 06/12/2014SE |
More from Medtronic, Inc.
| 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 Lilliput 1 Twin Reservoir with Phosphorilcholine Insert Surface in Oxygenation (Ph. I.S.I.O.) cleared by the FDA?
Dideco Lilliput 1 Twin Reservoir with Phosphorilcholine Insert Surface in Oxygenation (Ph. I.S.I.O.) (K001602) received a 510(k) decision of Substantially Equivalent on June 8, 2000, 15 days after the submission was received.
What is the product code of K001602?
The FDA product code is DTN – Reservoir, Blood, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.