Sarns Non-Filtered Venous Reservoir
FDA 510(k) K912915 · 3M Health Care, Ltd.
510(k) numberK912915
Submission
- Device name
- Sarns Non-Filtered Venous Reservoir
- Applicant
- 3M Health Care, Ltd.
Ann Arbor, MI, US - Received
- July 3, 1991
- Decision date
- September 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K911789 | Minimax (TM) Hardshell Venous Res W/Inte Card FiltDTP · Traditional | Medtronic Vascular | 08/20/1991SE |
More from Medtronic Vascular
| 510(k) | Device | Decision |
|---|---|---|
| K953904 | Sarns 9000 Universal Roller PumpDWB · Traditional | 04/19/1996SE |
| K926364 | Attest Brand Rapid Readout Biological Ind. #129XFRC · Traditional | 03/31/1995SE |
| K941534 | Modular VS-22 Cemented Femoral Hip SystemKWY · Traditional | 03/06/1995SE |
| K941748 | Steri-Vac Gas Sterilizer Model 8XLFLF · Traditional | 12/02/1994SE |
| K930681 | 3M Prevention Fabric Surgical Gown #78XXFYA · Traditional | 02/10/1994SE |
| K932307 | 3M Maxi-Driver II Dbattery Powered SystemKIJ · Traditional | 01/07/1994SE |
| K932422 | 3M Tegaderm HP Transparent DressingKGX · Traditional | 12/27/1993SE |
| K932446 | Injection SiteFPA · Traditional | 11/29/1993SE |
| K931968 | Cdi 100 Extracorporeal Hematocrit/Oxygen SaturatioDRY · Traditional | 11/10/1993SE |
| K933006 | Avi Infusion Pumps, Additional Intended UseFRN · Traditional | 10/25/1993SE |
Questions and answers
When was Sarns Non-Filtered Venous Reservoir cleared by the FDA?
Sarns Non-Filtered Venous Reservoir (K912915) received a 510(k) decision of Substantially Equivalent on September 25, 1991, 84 days after the submission was received.
What is the product code of K912915?
The FDA product code is DTP – Defoamer, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4230.