510(k) Premarket Notification

• Device Classification Name: catheter, percutaneous
• 510(K) Number: K120781
• Models: 1610560 AND 1610561, 1610570 AND 1610571, 1610580, 1610590
• Device Name: CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH
• Applicant: FUJI SYSTEMS CORP.; 3250 second avenue; san diego, CA 92103
• Contact: paul mason
• Regulation Number: 870.1250
• Classification Product Code: DQY
• Date Received: 03/15/2012
• Decision Date: 08/09/2012
• 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