FDA product code PTN: Reservoir, Blood, Cardiopulmonary Bypass, Exempt
PTN is the FDA product code for reservoir, blood, cardiopulmonary bypass, exempt. It is a Class II device, regulated under 21 CFR 870.4400 and reviewed by the Cardiovascular panel. Devices under PTN reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Reservoir, Blood, Cardiopulmonary Bypass, Exempt |
| Device class | Class II |
| Regulation | 21 CFR 870.4400 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Recalls for PTN devices
openFDA lists no recalls for product code PTN.
Frequently asked questions
What is FDA product code PTN?
PTN is the FDA product code for reservoir, blood, cardiopulmonary bypass, exempt. It is a Class II device, regulated under 21 CFR 870.4400 and reviewed by the Cardiovascular panel.
What device class is PTN?
Class II, regulation 21 CFR 870.4400. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PTN
- Run a recall and safety report across every PTN manufacturer
- Watch product code PTN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.