Cobe Smarxt VVR 4000 Filtered Hardshell Venous Reservoir
FDA 510(k) K002591 · Cobe Cardiovascular, Inc.
510(k) numberK002591
Submission
- Device name
- Cobe Smarxt VVR 4000 Filtered Hardshell Venous Reservoir
- Applicant
- Cobe Cardiovascular, Inc.
Arvada, CO, US - Received
- August 21, 2000
- Decision date
- September 13, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 Smarxt VVR 4000 Filtered Hardshell Venous Reservoir cleared by the FDA?
Cobe Smarxt VVR 4000 Filtered Hardshell Venous Reservoir (K002591) received a 510(k) decision of Substantially Equivalent on September 13, 2000, 23 days after the submission was received.
What is the product code of K002591?
The FDA product code is DTP – Defoamer, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4230.