PTD · Class II · 21 CFR 880.5965

FDA Product Code PTD: Subcutaneous Implanted Apheresis Port

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

Leading manufacturers include C.R. Bard, Inc. and Norfolk Medical Products, Inc..

3
Total
3
Cleared
209d
Avg days
2017
Since

FDA 510(k) Cleared Subcutaneous Implanted Apheresis Port Devices (Product Code PTD)

3 devices
1–3 of 3
Cleared Aug 20, 2020
TidalPort-AP Implantable Apheresis Vascular Access Port
K192291
Norfolk Medical Products, Inc.
General Hospital · 363d
Cleared Aug 02, 2019
PowerFlow Implantable Apheresis IV Port
K191143
C.R. Bard, Inc.
General Hospital · 94d
Cleared Apr 17, 2017
PowerFlow Apheresis I.V. Port
K163001
C.R. Bard, Inc.
General Hospital · 171d

About Product Code PTD - Regulatory Context