Extracorpeal Cardiotomy Blood Filter
FDA 510(k) K780653 · Cobe Laboratories, Inc.
510(k) numberK780653
Submission
- Device name
- Extracorpeal Cardiotomy Blood Filter
- Applicant
- Cobe Laboratories, Inc.
Mchenry, IL, US - Received
- April 19, 1978
- Decision date
- June 14, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOD – Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4270
- Specialty
- Cardiovascular
Other 510(k)s with product code JOD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K993060 | Gas FilterJOD · Traditional | Olson Medical Sales, Inc. | 03/28/2000SE |
| K890504 | Cardiotomy/Autotransfusion/Pleural Drainage VenousJOD · Traditional | Gish Biomedical, Inc. | 03/10/1989SE |
| K875095 | Pall Cardioplegia Plus Filter W/Posidyne MembraneJOD · Traditional | Pall Biomedical Products Co. | 02/29/1988SE |
| K874405 | Pall Stat Prime(Tm) Blood Filter for Extra. UseJOD · Traditional | Pall Biomedical Products Co. | 12/30/1987SE |
| K855067 | Swank Cardiotomy Suction Line Blood Filter CA100JOD · Traditional | Cobe Laboratories, Inc. | 02/26/1986SE |
| K841958 | Cardio Metrics Cardiotomy ReservoirJOD · Traditional | Sterile Design, Inc. | 10/15/1984SE |
| K830634 | Cardiotomy FilterJOD · Traditional | Texas Medical Products, Inc. | 06/30/1983SE |
| K823260 | Interface Cardiotomy Blood Filter #51JOD · Traditional | Medical, Inc. | 11/24/1982SE |
| K823259 | Interface Cardiotomy Blood Filter #50JOD · Traditional | Medical, Inc. | 11/24/1982SE |
| K812243 | Interface Cardiotomy Blood Filter #51JOD · Traditional | Medical, Inc. | 08/25/1981SE |
More from Medical, 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 |
| 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 Extracorpeal Cardiotomy Blood Filter cleared by the FDA?
Extracorpeal Cardiotomy Blood Filter (K780653) received a 510(k) decision of Substantially Equivalent on June 14, 1978, 56 days after the submission was received.
What is the product code of K780653?
The FDA product code is JOD – Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4270.