FDA 510(k) Application Details - K090427

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K090427
Device Name	Catheter, Intravascular, Diagnostic
Applicant	CURATIVE MEDICAL TECHNOLOGY, INC. 102 MISTLETOE ST. LAKE JACKSON, TX 77566 US Other 510(k) Applications for this Company
Contact	AMY MCKINNEY Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2009
Decision Date	01/29/2010
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	N
Expedited Review