21 CFR 870.4350 — Oxygenator, Cardiopulmonary Bypass
Cardiovascular (CV) · Part 870 Subpart E—Cardiovascular Surgical Devices · § 870.4350
Identification
A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | 2 | 254 | Life-Sustaining |
Special Controls
DTZ — Oxygenator, Cardiopulmonary Bypass
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”
eCFR
DTZ — Oxygenator, Cardiopulmonary Bypass
The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”
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