510(k) Premarket Notification

• Device Classification Name: adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
• 510(K) Number: K122301
• Models: 8210,8211, 8215,8216
• Device Name: GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE
• Applicant: VASCULAR SOLUTIONS ZERUSA LTD.; 6464 sycamore court; minneapolis, MN 55369
• Contact: jennifer ruether
• Regulation Number: 870.4290
• Classification Product Code: DTL
• Date Received: 08/01/2012
• Decision Date: 09/07/2012
• 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