Reservoir, Blood, Cardiopulmonary Bypass, Exempt
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Guangdong. 1 is a contract manufacturer.
- Alleva Medical (D.G.) Ltd Guangdong, contract manufacturer
What Is This Device?
This product code is the class II exempt counterpart of DTN, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.
How Is PTN Classified?
Reservoir, Blood, Cardiopulmonary Bypass, Exempt is FDA product code PTN, Class 2, 21 CFR 870.4400.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.