Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000 Filtered Hardshell Venous Reservoir
FDA 510(k) K004046 · Cobe Cardiovascular, Inc.
510(k) numberK004046
Submission
- Device name
- Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000 Filtered Hardshell Venous Reservoir
- Applicant
- Cobe Cardiovascular, Inc.
Arvada, CO, US - Received
- December 29, 2000
- Decision date
- April 26, 2001
- 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 |
| 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 |
| K984322 | Dideco D920, Lilliput 1 Twin ReservoirDTP · Traditional | Dideco S.P.A. | 03/02/1999SE |
| 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 |
|---|---|---|
| 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 |
| K033641 | Smarxt VVR4000I Plus Filtered Hardshell Venous Reservoir, Model 439914800DTN · Special | 12/11/2003SE |
| 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 |
Questions and answers
When was Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000 Filtered Hardshell Venous Reservoir cleared by the FDA?
Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000 Filtered Hardshell Venous Reservoir (K004046) received a 510(k) decision of Substantially Equivalent on April 26, 2001, 118 days after the submission was received.
What is the product code of K004046?
The FDA product code is DTP – Defoamer, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4230.