FDA 510(k) Application Details - K113424

Device Classification Name	Catheter, Straight   More FDA Info for this Device
510(K) Number	K113424
Device Name	Catheter, Straight
Applicant	ASTRA TECH AB 11234 EL CAMINO REAL, SUITE 200 SAN DIEGO, CA 92130 US Other 510(k) Applications for this Company
Contact	FLOYD G LARSON Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2011
Decision Date	04/17/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review