Subcutaneous Implanted Apheresis Port
FDA product code PTD · Class II (moderate risk) · 21 CFR 880.5965 · General Hospital
A subcutaneous implanted apheresis port is a prescription device intended for patient therapies requiring repeated access to the vascular system and long-term therapeutic apheresis
3510(k) clearances
0PMA approvals
0recalls
Implantimplanted device
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192291 | TidalPort-AP Implantable Apheresis Vascular Access PortPTD · Traditional | Norfolk Medical Products, Inc. | 08/20/2020SE |
| K191143 | PowerFlow Implantable Apheresis IV PortPTD · Traditional | C.R. Bard, Inc. | 08/02/2019SE |
| K163001 | PowerFlow Apheresis I.V. PortPTD · Traditional | C.R. Bard, Inc. | 04/17/2017SE |