FDA 510(k) Application Details - K181446

Device Classification Name	Port & Catheter, Implanted, Subcutaneous, Intravascular   More FDA Info for this Device
510(K) Number	K181446
Device Name	Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant	C.R. Bard, Inc. 605 North 5600 West Salt Lake City, UT 84116 US Other 510(k) Applications for this Company
Contact	Jeff Peterson Other 510(k) Applications for this Contact
Regulation Number	880.5965   More FDA Info for this Regulation Number
Classification Product Code	LJT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2018
Decision Date	07/08/2019
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