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))
| Device Type ID | 984 |
| Device Name | Reservoir, Blood, Cardiopulmonary Bypass, Exempt |
| Physical State | Exemption Is Limited To Cardiopulmonary Bypass Blood Reservoirs That Do Not Contain Defoamers Or Blood Filters. |
| Technical Method | 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)) |
| Target Area | 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)) |
| Regulation Description | Cardiopulmonary Bypass Blood Reservoir. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 870.4400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PTN |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 984 |
| Device | Reservoir, Blood, Cardiopulmonary Bypass, Exempt |
| Product Code | PTN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiopulmonary Bypass Blood Reservoir. |
| CFR Regulation Number | 870.4400 [🔎] |