FDA 510(k) Application Details - K103153

Device Classification Name	Catheters, Transluminal Coronary Angioplasty, Percutaneous   More FDA Info for this Device
510(K) Number	K103153
Device Name	VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER
Applicant	ABBOTT VASCULAR-CARDIAC THERAPIES 26531 YNEZ RD. MAILING P.O. BOX 9018 TEMECULA, CA 92589 9018 Other 510(k) Applications for this Company   More Company Info and Competitors
Contact	SUZANNE REDMAN 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	10/14/2010
Decision Date	12/30/2010
Decision	SE - Substantially Equivalent
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review	N