FDA 510(k) Application Details - K122402

Device Classification Name	Port & Catheter, Implanted, Subcutaneous, Intravascular   More FDA Info for this Device
510(K) Number	K122402
Device Name	Port & Catheter, Implanted, Subcutaneous, Intravascular
Applicant	PFM MEDICAL, INC 1815 ASTON AVE, SUITE 106 CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	Salvadore Palomares, RAC 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	08/07/2012
Decision Date	07/16/2013
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