Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model Be-Vbt 160, Beq-Vbt 160
FDA 510(k) K082412 · Mapquet Cardiopulmonary AG
510(k) numberK082412
Submission
- Device name
- Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model Be-Vbt 160, Beq-Vbt 160
- Applicant
- Mapquet Cardiopulmonary AG
Hirrlingen, DE - Received
- August 21, 2008
- Decision date
- November 10, 2008
- 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 |
| K004046 | Cobe VVR 4000 Filtered Hardshell Venous Reservoir, Cobe Smarxt VVR 4000 Filtered…DTP · Traditional | Cobe Cardiovascular, Inc. | 04/26/2001SE |
| 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 |
Questions and answers
When was Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model Be-Vbt 160, Beq-Vbt 160 cleared by the FDA?
Venous Bubble Trap, Model VBT 160; Venous Bubble Trap with Bioline Coating, Model Be-Vbt 160, Beq-Vbt 160 (K082412) received a 510(k) decision of Substantially Equivalent on November 10, 2008, 81 days after the submission was received.
What is the product code of K082412?
The FDA product code is DTP – Defoamer, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4230.