510(k) Premarket Notification

• Device Classification Name: device, neurovascular embolization
• 510(K) Number: K120908
• Device Name: HYDROCOIL EMBOLIC SYSTEM (HES)
• Applicant: MICROVENTION, INC.; 1311 valencia ave; tustin, CA 92780
• Contact: laraine pangelina
• Regulation Number: 882.5950
• Classification Product Code: HCG
• Subsequent Product Code: KRD
• Date Received: 03/26/2012
• Decision Date: 04/25/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Neurology
• Review Advisory Committee: Neurology
• summary: summary
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No