FDA 510(k) Application Details - K130725

Device Classification Name	Catheter, Umbilical Artery   More FDA Info for this Device
510(K) Number	K130725
Device Name	Catheter, Umbilical Artery
Applicant	COVIDIEN LP, FORMERLY REGISTERED AS KENDALL 15 HAMPSHIRE ST. MANSFIELD, MA 02048 US Other 510(k) Applications for this Company
Contact	DOLLY MISTRY Other 510(k) Applications for this Contact
Regulation Number	880.5200   More FDA Info for this Regulation Number
Classification Product Code	FOS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/18/2013
Decision Date	04/17/2013
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