DeviceClearance

Product code PTD— General Hospital

PowerFlow Apheresis I.V. Port

Classification name
Subcutaneous Implanted Apheresis Port
Device class
Class 2
Regulation
21 CFR 880.5965
Advisory panel
General Hospital
Total cleared
3
First cleared
Most recent

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”

— U.S. Food and Drug Administration, device classification record for product code PTD under 21 CFR 880.5965, via openFDA

Market context for product code PTD

FDA has cleared 3 devices under product code PTD between 2017 and 2020, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PTD

Recent clearances under product code PTD

Data sourced from openFDA. This site is unofficial and independent of the FDA.