Cobe Centry 2 Bicart Option Kit
FDA 510(k) K905793 · Cobe Laboratories, Inc.
510(k) numberK905793
Submission
- Device name
- Cobe Centry 2 Bicart Option Kit
- Applicant
- Cobe Laboratories, Inc.
Lakewood, CO, US - Received
- December 27, 1990
- Decision date
- February 12, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FKP – System, Dialysate Delivery, Single Patient
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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More from Integrated Biomedical Technology, Inc.
| 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 |
| 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 |
| K902671 | Cobe Autologous Blood Salvage Reserv W/W/O FilterCAC · Traditional | 07/17/1990SE |
Questions and answers
When was Cobe Centry 2 Bicart Option Kit cleared by the FDA?
Cobe Centry 2 Bicart Option Kit (K905793) received a 510(k) decision of Substantially Equivalent on February 12, 1991, 47 days after the submission was received.
What is the product code of K905793?
The FDA product code is FKP – System, Dialysate Delivery, Single Patient, a Class II (moderate risk) device regulated under 21 CFR 876.5820.