FDA 510(k) Application Details - K113103

Device Classification Name	More FDA Info for this Device
510(K) Number	K113103
Device Name	SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE
Applicant	REX MEDICAL 55 Northern Blvd. Suite 200 Great Neck, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLDSTEIN-FALK Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/19/2011
Decision Date	05/22/2012
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