GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)
Device Facts
| Record ID | K862068 |
|---|---|
| Device Name | GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON) |
| Applicant | Gelman Sciences, Inc. |
| Product Code | DTM · Cardiovascular |
| Decision Date | Aug 8, 1986 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.4260 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”
