FDA 510(k) Application Details - K112382

Device Classification Name	More FDA Info for this Device
510(K) Number	K112382
Device Name	TERUMO ASPRIATION CATHETER
Applicant	Terumo Medical Corporation 950 ELKTON BLVD ELKTON, MD 21921 US Other 510(k) Applications for this Company
Contact	DANIEL R PLONSKI Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QEZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/2011
Decision Date	12/14/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review