PTN — Reservoir, Blood, Cardiopulmonary Bypass, Exempt Class II
FDA product code PTN covers "Reservoir, Blood, Cardiopulmonary Bypass, Exempt", a Class II medical device regulated under 21 CFR 870.4400. Submissions are reviewed by the Cardiovascular panel.
Classification Details
- Product Code
- PTN
- Device Class
- Class II
- Regulation Number
- 870.4400
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
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.