Cobe Vacuum Relief Check Valve
FDA 510(k) K982406 · Cobe Cardiovascular, Inc.
510(k) numberK982406
Submission
- Device name
- Cobe Vacuum Relief Check Valve
- Applicant
- Cobe Cardiovascular, Inc.
Arvada, CO, US - Received
- July 10, 1998
- Decision date
- October 7, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MJJ – Cpb Check Valve, Retrograde Flow, In-Line
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4400
- Specialty
- Cardiovascular
Other 510(k)s with product code MJJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182442 | MiniGuard Arterial Safety ValveMJJ · Traditional | Quest Medical, Inc. | 11/06/2018SE |
| K142500 | One Way Soft ValveMJJ · Traditional | Terumo Cardiovascular Systems Corporation | 01/29/2015SE |
| K001245 | 3T L. V. Control ValveMJJ · Traditional | 3t Medical Systems, LLC | 08/15/2001SE |
| K992785 | Ibc Floguard, Model 6050MJJ · Traditional | International Biophysics Corp. | 01/14/2000SE |
| K960937 | Suction Safety DeviceMJJ · Traditional | R D Intl. | 06/05/1996SE |
| K922781 | Flow Conrol ValveMJJ · Traditional | American Omni Medical, Inc. | 03/08/1993SE |
| K922356 | Flow Control Valve, Cat. No. ACV-38MJJ · Traditional | American Omni Medical, Inc. | 02/12/1993SE |
| K921500 | Centri-Safe(Tm) ValveMJJ · Traditional | Cardio Systems, Inc. | 09/15/1992SE |
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| 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 |
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Questions and answers
When was Cobe Vacuum Relief Check Valve cleared by the FDA?
Cobe Vacuum Relief Check Valve (K982406) received a 510(k) decision of Substantially Equivalent on October 7, 1998, 89 days after the submission was received.
What is the product code of K982406?
The FDA product code is MJJ – Cpb Check Valve, Retrograde Flow, In-Line, a Class II (moderate risk) device regulated under 21 CFR 870.4400.