Cardiotomy/Autotransfusion/Pleural Drainage Venous
FDA 510(k) K890504 · Gish Biomedical, Inc.
510(k) numberK890504
Submission
- Device name
- Cardiotomy/Autotransfusion/Pleural Drainage Venous
- Applicant
- Gish Biomedical, Inc.
Santa Ana, CA, US - Received
- February 1, 1989
- Decision date
- March 10, 1989
- 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
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|---|---|---|---|
| K993060 | Gas FilterJOD · Traditional | Olson Medical Sales, Inc. | 03/28/2000SE |
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| 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 |
| K781383 | Interface Cardiotomy Blood FilterJOD · Traditional | Medical, Inc. | 09/27/1978SE |
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Questions and answers
When was Cardiotomy/Autotransfusion/Pleural Drainage Venous cleared by the FDA?
Cardiotomy/Autotransfusion/Pleural Drainage Venous (K890504) received a 510(k) decision of Substantially Equivalent on March 10, 1989, 37 days after the submission was received.
What is the product code of K890504?
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.