PTD — Subcutaneous Implanted Apheresis Port Class II
FDA product code PTD covers "Subcutaneous Implanted Apheresis Port", a Class II medical device regulated under 21 CFR 880.5965. Submissions are reviewed by the General Hospital panel. Devices under this code are implants. At least 3 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PTD
- Device Class
- Class II
- Regulation Number
- 880.5965
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- Yes
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