Cobe/Stockert Battery Module
FDA 510(k) K802714 · Cobe Laboratories, Inc.
510(k) numberK802714
Submission
- Device name
- Cobe/Stockert Battery Module
- Applicant
- Cobe Laboratories, Inc.
Mchenry, IL, US - Received
- October 31, 1980
- Decision date
- November 26, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWB – Pump, Blood, Cardiopulmonary Bypass, Roller Type
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4370
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DWB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump…DWB · Special | Terumo Cardiovascular Systems Corporation | 11/17/2016SE |
| K131618 | Large (6) Roller Pump for Terumo Advanced Perfusion System 1; Large (6) Roller Pump for…DWB · Traditional | Terumo Cardiovascular Systems Corporation | 09/27/2013SE |
| K112587 | Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color,DWB · Traditional | Terumo Cardiovascular Systems Corp. | 12/19/2011SE |
| K973237 | Css-Cardioplegia Safety SystemDWB · Traditional | Medtronic Bio-Medicus, Inc. | 04/27/1998SE |
| K972321 | S3 Mast PumpDWB · Traditional | Stoeckert Instrumente | 02/27/1998SE |
| K971520 | S3 Cyclic RPM ControlDWB · Traditional | Stoeckert Instrumente | 09/10/1997SE |
| K960974 | Cobe Century Perfusion PumpDWB · Traditional | Cobe Cardiovascular, Inc. | 07/14/1997SE |
| K953904 | Sarns 9000 Universal Roller PumpDWB · Traditional | 3M Health Care, Ltd. | 04/19/1996SE |
| K953901 | Sarns 800 Roller PumpDWB · Traditional | 3M Health Care, Sarns | 04/19/1996SE |
| K955038 | Stockert S3 Double Head Pump ModuleDWB · Traditional | Stoeckert Instrumente | 02/21/1996SE |
More from Stoeckert Instrumente
| 510(k) | Device | Decision |
|---|---|---|
| K923272 | Cobe Cms-Hf Hollow Fiber Membrane OxygenatorDTZ · Traditional | 05/11/1993SE |
| K900105 | Cobe Spectra Blood Component Separator TherapeuticLKN · Traditional | 03/22/1991SE |
| K905793 | Cobe Centry 2 Bicart Option KitFKP · Traditional | 02/12/1991SE |
| K905388 | Cobe Centrysystem 3 Bicart Option KitFKP · Traditional | 02/11/1991SE |
| K904336 | New Cobe Saturation/Hematocrit MonitorGKF · Traditional | 12/27/1990SE |
| K902631 | Cobe ICU Conversion KitDTN · Traditional | 12/17/1990SE |
| K902437 | Cobe Cardiotomy Reservoir with or Without FilterDTP · Traditional | 12/17/1990SE |
| K904566 | New Cobe Centrysystem(Tm) 100 HG DialyzerFJI · Traditional | 12/12/1990SE |
| K902758 | Cobe Saturation/Hematocrit Monitor W/ Fiber OpticDQA · Traditional | 08/23/1990SE |
| K902759 | Cobe Closed Wound Drainage KitCAC · Traditional | 07/18/1990SE |
Questions and answers
When was Cobe/Stockert Battery Module cleared by the FDA?
Cobe/Stockert Battery Module (K802714) received a 510(k) decision of Substantially Equivalent on November 26, 1980, 26 days after the submission was received.
What is the product code of K802714?
The FDA product code is DWB – Pump, Blood, Cardiopulmonary Bypass, Roller Type, a Class II (moderate risk) device regulated under 21 CFR 870.4370.