PTD

Subcutaneous Implanted Apheresis Port

Product code

PTD

Device name

Subcutaneous Implanted Apheresis Port

Device class

Class 2

21 CFR

21 CFR 880.5965

Medical specialty

General Hospital

Marketing pathway

510(K)

Flag

Implant

510(k) clearances (all years, FDA)

3 (all years; only the last 3 years are listed here)

FDA classification 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

Definition text from the FDA device classification database (U.S. federal government work, public domain).