Smarxt VVR4000I Plus Filtered Hardshell Venous Reservoir, Model 439914800
FDA 510(k) K033641 · Cobe Cardiovascular, Inc.
510(k) numberK033641
Submission
- Device name
- Smarxt VVR4000I Plus Filtered Hardshell Venous Reservoir, Model 439914800
- Applicant
- Cobe Cardiovascular, Inc.
Arvada, CO, US - Received
- November 20, 2003
- Decision date
- December 11, 2003
- 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 |
|---|---|---|
| K050111 | Smarxt BMR 1900 Closed Venous Reservoir BagDTN · Abbreviated | 03/08/2005SE |
| K042473 | Cobe Angel Whole Blood Separation SystemJQC · Abbreviated | 11/19/2004SE |
| K040184 | Dideco Micro 40 Ph.I.S.I.O. Adult Arterial FilterDTM · Special | 02/26/2004SE |
| K030462 | Cobe Revolution Centrifugal Blood Pump with PC, Model 050300700KFM · Special | 03/06/2003SE |
| K021830 | Sorin Biomedica Smarxt BCD Vanguard Surface Modified Cardioplegia SystemDTR · Special | 07/02/2002SE |
| K011835 | Cobe RevolutionKFM · Abbreviated | 02/12/2002SE |
| K013480 | Cobe Smarxt Optimin Surface Modified Hollow Fiber Membrane OxygenatorDTZ · Special | 11/16/2001SE |
| K012763 | Sorin Biomedica Smart BCD Vanguard,Surface Modified Blood Cardioplegia SystemDRT · Abbreviated | 11/15/2001SE |
| K001509 | Stockert V172 Series Venous Femoral CannulaeDWF · Abbreviated | 10/26/2001SE |
| K012898 | Modification to: CSC14 Blood Cardioplegia SystemDTR · Special | 09/17/2001SE |
Questions and answers
When was Smarxt VVR4000I Plus Filtered Hardshell Venous Reservoir, Model 439914800 cleared by the FDA?
Smarxt VVR4000I Plus Filtered Hardshell Venous Reservoir, Model 439914800 (K033641) received a 510(k) decision of Substantially Equivalent on December 11, 2003, 21 days after the submission was received.
What is the product code of K033641?
The FDA product code is DTN – Reservoir, Blood, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4400.