PTD
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Subcutaneous Implanted Apheresis Port
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5965
- Medical specialty
- General Hospital
- Flags
- Implant
- FDA definition
- 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
- Adverse events (MAUDE)
- 2019: 35 · 2020: 18 · 2021: 15 · 2023: 25 · 2024: 22 · 2025: 27
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TidalPort-AP Implantable Apheresis Vascular Access Port (K192291) | Norfolk Medical Products, Inc. | 2020-08-20 |
| PowerFlow Implantable Apheresis IV Port (K191143) | C.R. Bard, Inc. | 2019-08-02 |
| PowerFlow Apheresis I.V. Port (K163001) | C.R. Bard, Inc. | 2017-04-17 |
Track PTD automatically
Every clearance here is in the API, with alerts when new ones post.