21 CFR 870.4260 — Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cardiovascular (CV) · Part 870 Subpart E—Cardiovascular Surgical Devices · § 870.4260
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.
Classification Rationale
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.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DTM | Filter, Blood, Cardiopulmonary Bypass, Arterial Line | 2 | 96 | Life-Sustaining |
Special Controls
DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line
*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.”
eCFR
DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line
The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.”
Ecfr Llm
