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Subcutaneous Implanted Apheresis Port

FDA product code PTD · 3 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.5965
Review panel
HO
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2017-04-17 – 2020-08-20

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

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