FDA 510(k) Application Details - K192291

Device Classification Name	More FDA Info for this Device
510(K) Number	K192291
Device Name	TidalPort-AP Implantable Apheresis Vascular Access Port
Applicant	Norfolk Medical Products, Inc. 7350 N. Ridgeway Avenue Skokie, IL 60076 US Other 510(k) Applications for this Company
Contact	Natan Pheil Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PTD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/23/2019
Decision Date	08/20/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review