FDA 510(k) Application Details - K123264

Device Classification Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous   More FDA Info for this Device
510(K) Number	K123264
Device Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant	INTUIT MEDICAL, LLC 6018 EAGLE'S REST TRAIL SUGAR HILL, GA 30518 US Other 510(k) Applications for this Company
Contact	JACK C GRIFFIS Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LOX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/18/2012
Decision Date	01/16/2013
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