Product code
PTN: Reservoir, blood, cardiopulmonary bypass, exempt
FDA product code · Class II · Cardiovascular
Key facts
| Product code | PTN |
|---|---|
| Device | Reservoir, blood, cardiopulmonary bypass, exempt |
| Device class | Class II |
| Regulation number | 870.4400 |
| Review panel | Cardiovascular |
| Medical specialty | Cardiovascular |
| Submission type | 510(K) Exempt |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | 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… |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database