FDA 510(k) Application Details - K122422

Device Classification Name	More FDA Info for this Device
510(K) Number	K122422
Device Name	PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER
Applicant	CAREFUSION 1500 WAUKEGAN ROAD MCGAW PARK \, IL 60085 US Other 510(k) Applications for this Company
Contact	JOY GREIDANUS Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2012
Decision Date	10/24/2012
Decision	SESK - SUBST EQUIV - KIT
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