FDA 510(k) Application Details - K232737

Device Classification Name	Port & Catheter, Implanted, Subcutaneous, Intravascular   More FDA Info for this Device
510(K) Number	K232737
Device Name	Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant	Bard Peripheral Vascular, Inc. 1625 W 3rd St Tempe, AZ 85281 US Other 510(k) Applications for this Company
Contact	Kristen Ortiz 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	09/07/2023
Decision Date	12/08/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review