JOD · Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4270 · Class 2
Overview
| Product Code | JOD |
|---|---|
| Device Name | Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4270 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A cardiopulmonary bypass cardiotomy suction line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (a blood clot or a piece of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. This device is intended for use in the cardiotomy suction line.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K993060 | GAS FILTER | Olson Medical Sales, Inc. | Mar 28, 2000 | SESE |
| K890504 | CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUS | Gish Biomedical, Inc. | Mar 10, 1989 | SESE |
| K875095 | PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE | Pall Biomedical Products Co. | Feb 29, 1988 | SESE |
| K874405 | PALL STAT PRIME(TM) BLOOD FILTER FOR EXTRA. USE | Pall Biomedical Products Co. | Dec 30, 1987 | SESE |
| K855067 | SWANK CARDIOTOMY SUCTION LINE BLOOD FILTER CA100 | Cobe Laboratories, Inc. | Feb 26, 1986 | SESE |
| K841958 | CARDIO METRICS CARDIOTOMY RESERVOIR | Sterile Design, Inc. | Oct 15, 1984 | SESE |
| K830634 | CARDIOTOMY FILTER | Texas Medical Products, Inc. | Jun 30, 1983 | SESE |
| K823260 | INTERFACE CARDIOTOMY BLOOD FILTER #51 | Medical, Inc. | Nov 24, 1982 | SESE |
| K823259 | INTERFACE CARDIOTOMY BLOOD FILTER #50 | Medical, Inc. | Nov 24, 1982 | SESE |
| K812243 | INTERFACE CARDIOTOMY BLOOD FILTER #51 | Medical, Inc. | Aug 25, 1981 | SESE |
| K781383 | INTERFACE CARDIOTOMY BLOOD FILTER | Medical, Inc. | Sep 27, 1978 | SESE |
| K780653 | EXTRACORPEAL CARDIOTOMY BLOOD FILTER | Cobe Laboratories, Inc. | Jun 14, 1978 | SESE |
Top Applicants
- Medical, Inc. — 4 clearances
- Pall Biomedical Products Co. — 2 clearances
- Cobe Laboratories, Inc. — 2 clearances
- Texas Medical Products, Inc. — 1 clearance
- Sterile Design, Inc. — 1 clearance
