Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
The Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass is a cardiovascular device used during open-heart surgery to filter blood returning through the cardiotomy suction line of the cardiopulmonary bypass circuit, removing debris, cellular aggregates, and embolic material to prevent them from re-entering the patient's circulation. This device is FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification to demonstrate substantial equivalence prior to marketing. It carries product code JOD and is regulated under 21 CFR 870.4270, within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
Research product code JOD in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- JOD
- Device Class
- FDA class 2
- Regulation Number
- 870.4270
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K993060 | GAS FILTER | Mar 28, 2000 | Substantially Equivalent | Olson Medical Sales, Inc. |
| K890504 | CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS | Mar 10, 1989 | Substantially Equivalent | Gish Biomedical, Inc. |
| K875095 | PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE | Feb 29, 1988 | Substantially Equivalent | Pall Biomedical Products Co. |
| K874405 | PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE | Dec 30, 1987 | Substantially Equivalent | Pall Biomedical Products Co. |
| K855067 | SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 | Feb 26, 1986 | Substantially Equivalent | Cobe Laboratories, Inc. |
| K841958 | CARDIO METRICS CARDIOTOMY RESERVOIR | Oct 15, 1984 | Substantially Equivalent | Sterile Design, Inc. |
| K830634 | CARDIOTOMY FILTER | Jun 30, 1983 | Substantially Equivalent | Texas Medical Products, Inc. |
| K823260 | INTERFACE CARDIOTOMY BLOOD FILTER #51 | Nov 24, 1982 | Substantially Equivalent | Medical, Inc. |
| K823259 | INTERFACE CARDIOTOMY BLOOD FILTER #50 | Nov 24, 1982 | Substantially Equivalent | Medical, Inc. |
| K812243 | INTERFACE CARDIOTOMY BLOOD FILTER #51 | Aug 25, 1981 | Substantially Equivalent | Medical, Inc. |
| K781383 | INTERFACE CARDIOTOMY BLOOD FILTER | Sep 27, 1978 | Substantially Equivalent | Medical, Inc. |
| K780653 | EXTRACORPEAL CARDIOTOMY BLOOD FILTER | Jun 14, 1978 | Substantially Equivalent | Cobe Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.