510(k) Premarket Notification

• Device Classification Name: device, vascular, for promoting embolization
• 510(K) Number: K122316
• Model: 45-450305,45-450505,45-450510,45-450515
• Device Name: AZUR DETACHABLE 35
• Applicant: MICROVENTION, INC.; 1311 valencia ave; tustin, CA 92780
• Contact: cynthia valenzuela
• Regulation Number: 870.3300
• Classification Product Code: KRD
• Date Received: 08/01/2012
• Decision Date: 08/29/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Cardiovascular
• Review Advisory Committee: Cardiovascular
• summary: summary
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No