Dideco Flexible Reservoir -- Product Designation 5063
FDA 510(k) K945065 · Sorin Biomedical, Inc.
510(k) numberK945065
Submission
- Device name
- Dideco Flexible Reservoir -- Product Designation 5063
- Applicant
- Sorin Biomedical, Inc.
Irvine, CA, US - Received
- October 14, 1994
- Decision date
- May 19, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code DTN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirsDTN · Traditional | Sorin Group Italia S.R.L. | 12/22/2025SE |
| 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 |
|---|---|---|
| K990103 | Monolyth C 600 and 1200 Hollow Fiber Membrane Lung with Integrated Softshell Venous…DTZ · Traditional | 11/05/1999SE |
| K963759 | Dideco Compact-A and Compact-M Autotransfusion SystemsCAC · Traditional | 02/20/1998SE |
| K963758 | Code 150 Blood Component Collection Set and with Direct Draw LineCAC · Traditional | 02/20/1998SE |
| K964908 | VRF40 Venous Reservoir with Integral Cardiotomy FilterDTN · Traditional | 09/03/1997SE |
| K964907 | Venomidicard Pediatric Venous Reservoir with Integralcardiotomy Filter/Midicard…DTN · Traditional | 08/21/1997SE |
| K961869 | Dideco Newborn/Infant Arterial Filters: D735 Micro 20 and D736 Micro 40DTM · Traditional | 08/12/1996SE |
| K952270 | Dideco Adult Arterial Filters D732 Micro 20 W/20, D734 Micro 40 W/40 Micron ScreenDTM · Traditional | 08/21/1995SE |
| K945198 | Dideco Pediatric Arterial FiltersDTM · Traditional | 06/27/1995SE |
| K941215 | Venomidicard Infant/ Pediatric Venous Cardiotomy ReservoirDTN · Traditional | 05/10/1995SE |
| K942582 | Sorin Blood Cardioplegia ConsoleDTQ · Traditional | 01/27/1995SE |
Questions and answers
When was Dideco Flexible Reservoir -- Product Designation 5063 cleared by the FDA?
Dideco Flexible Reservoir -- Product Designation 5063 (K945065) received a 510(k) decision of Substantially Equivalent on May 19, 1995, 217 days after the submission was received.
What is the product code of K945065?
The FDA product code is DTN – Reservoir, Blood, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.