510(k) Premarket Notification

• Device Classification Name: wire, guide, catheter
• 510(K) Number: K122573
• Device Name: HI-TORQUE COMMAND GUIDE WIRE FAMILY
• Applicant: ABBOTT VASCULAR INC.; 26531 ynez road, building g; maling p.o. 9018; temecula, CA 92590 9018
• Contact: kay setzer
• Regulation Number: 870.1330
• Classification Product Code: DQX
• Date Received: 08/23/2012
• Decision Date: 11/20/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Cardiovascular
• Review Advisory Committee: Cardiovascular
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No