510(k) Premarket Notification

• Device Classification Name: wire, guide, catheter
• 510(K) Number: K112381
• Model: 1012587, 1012588, 1012589, 1012590, 1012591, 1012592, 1012593, 1012594, 1012595
• Device Name: HI TORQUE CONNECT GUIDEWIRE
• Applicant: LAKE REGION MEDICAL; lake region med intl r&d ctr; parkmore west business; galway,
• Contact: kenny walsh
• Regulation Number: 870.1330
• Classification Product Code: DQX
• Date Received: 08/17/2011
• Decision Date: 11/03/2011
• 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