510(k) Premarket Notification

• Device Classification Name: introducer, catheter
• 510(K) Number: K121504
• Device Name: SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS
• Applicant: TOGO MEDIKIT CO., LTD.; 611 west 5th street; austin, TX 78701
• Contact: heather crawford
• Regulation Number: 870.1340
• Classification Product Code: DYB
• Date Received: 05/21/2012
• Decision Date: 09/27/2012
• 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