Product code PTD

Device name

Subcutaneous Implanted Apheresis Port

Medical specialty

General Hospital

Device class

2

Regulation number

880.5965

Review panel

HO

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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

Source

FDA openFDA device classification dataset