510(k) Premarket Notification

• Device Classification Name: catheter,intravascular,therapeutic,short-term less than 30 days
• 510(K) Number: K120839
• Models: REF 00002, REF 00003, REF 00004, REF00001
• Device Name: NOVACATH SECURE IV CATHETER SYSTEM-18G
• Applicant: TANGENT MEDICAL TECHNOLOGIES, INC.; 8170 jackson rd, ste a; ann arbor, MI 48103
• Contact: kay fuller
• Regulation Number: 880.5200
• Classification Product Code: FOZ
• Date Received: 03/20/2012
• Decision Date: 07/20/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: General Hospital
• Review Advisory Committee: General Hospital
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No