FDA product code PTD: Subcutaneous Implanted Apheresis Port
PTD is the FDA product code for subcutaneous implanted apheresis port. It is a Class II device, regulated under 21 CFR 880.5965 and reviewed by the General Hospital panel. FDA has cleared 3 510(k) submissions under PTD, from 2 different applicants. The average 510(k) review took 209 days (median 171).
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
Classification
| Field | Value |
|---|---|
| Device name | Subcutaneous Implanted Apheresis Port |
| Device class | Class II |
| Regulation | 21 CFR 880.5965 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PTD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 171 |
| 2019 | 1 | 94 |
| 2020 | 1 | 363 |
Compare with all 510(k) review times · Search every PTD clearance
Top PTD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| C.R. Bard, Inc. | 2 | 2019-08-02 |
| Norfolk Medical Products, Inc. | 1 | 2020-08-20 |
Most recent PTD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K192291 | Norfolk Medical Products, Inc. | TidalPort-AP Implantable Apheresis Vascular Access Port | 2020-08-20 | 363 |
| K191143 | C.R. Bard, Inc. | PowerFlow Implantable Apheresis IV Port | 2019-08-02 | 94 |
| K163001 | C.R. Bard, Inc. | PowerFlow Apheresis I.V. Port | 2017-04-17 | 171 |
Recalls for PTD devices
openFDA lists no recalls for product code PTD.
Frequently asked questions
What is FDA product code PTD?
PTD is the FDA product code for subcutaneous implanted apheresis port. It is a Class II device, regulated under 21 CFR 880.5965 and reviewed by the General Hospital panel.
What device class is PTD?
Class II, regulation 21 CFR 880.5965. Typical premarket route: 510(k).
How long does a 510(k) take for product code PTD?
Across 3 cleared submissions the average was 209 days from receipt to decision (median 171).
Which companies have the most PTD clearances?
C.R. Bard, Inc. (2); Norfolk Medical Products, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PTD
- Run a recall and safety report across every PTD manufacturer
- Watch product code PTD 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.
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