Subcutaneous Implanted Apheresis Port
The Subcutaneous Implanted Apheresis Port is an implantable prescription device intended for patients requiring repeated vascular system access for long-term therapeutic apheresis procedures, providing a subcutaneous port that allows reliable repeated vascular access without repeated venipuncture. It is classified as FDA Class 2 under 21 CFR 880.5965 in the General Hospital specialty, requiring 510(k) premarket notification. Product code PTD; flagged as an implant; not life-sustaining.
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Basic Information
- Product Code
- PTD
- Device Class
- FDA class 2
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K192291 | TidalPort-AP Implantable Apheresis Vascular Access Port | Aug 20, 2020 | Substantially Equivalent | Norfolk Medical Products, Inc. |
| K191143 | PowerFlow Implantable Apheresis IV Port | Aug 02, 2019 | Substantially Equivalent | C.R. Bard, Inc. |
| K163001 | PowerFlow Apheresis I.V. Port | Apr 17, 2017 | Substantially Equivalent | C.R. Bard, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.