FDA 510(k) Application Details - K113819

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K113819
Device Name	Catheter, Intravascular, Diagnostic
Applicant	PEDIACATH INC. 611 WEST 5TH STREET AUSTIN, TX 78701 US Other 510(k) Applications for this Company
Contact	CAROLINE TONTINI 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	12/27/2011
Decision Date	07/11/2012
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