Cobe Brat 2 System with Modified Standard Volume Processing Set
FDA 510(k) K974897 · Cobe Cardiovascular, Inc.
510(k) numberK974897
Submission
- Device name
- Cobe Brat 2 System with Modified Standard Volume Processing Set
- Applicant
- Cobe Cardiovascular, Inc.
Arvada, CO, US - Received
- December 31, 1997
- Decision date
- March 31, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAC – Apparatus, Autotransfusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5830
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K240426 | Aventus Clot Management SystemCAC · Traditional | Inquis Medical | 05/14/2024SE |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets)CAC · Special | Sorin Group Italia S.R.L. | 04/29/2024SE |
| K231782 | FlowSaver Blood Return System (80-101)CAC · Special | Inari Medical, Inc. | 07/14/2023SE |
| K221483 | FlowSaver Blood Return SystemCAC · Traditional | Inari Medical, Inc. | 02/17/2023SE |
| K221722 | Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US)CAC · Traditional | Haemonetics Corporation | 11/15/2022SE |
| K201305 | Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction…CAC · Traditional | Atrium Medical Corporation | 09/03/2021SE |
| K210862 | Hemafuse SystemCAC · Traditional | Sisu Global Health | 07/29/2021SE |
| K210176 | FlowSaver Blood FilterCAC · Traditional | Inari Medical | 07/22/2021SE |
| K210089 | CATSmart, Automated Blood Processing Autotransfusion SystemCAC · Special | Fresenius Kabi AG | 02/11/2021SE |
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| 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 Brat 2 System with Modified Standard Volume Processing Set cleared by the FDA?
Cobe Brat 2 System with Modified Standard Volume Processing Set (K974897) received a 510(k) decision of Substantially Equivalent on March 31, 1998, 90 days after the submission was received.
What is the product code of K974897?
The FDA product code is CAC – Apparatus, Autotransfusion, a Class II (moderate risk) device regulated under 21 CFR 868.5830.