510(k) Premarket Notification

• Device Classification Name: catheter, embolectomy
• 510(K) Number: K111182
• Model: 109681-001
• Device Name: ANGIOJET SOLENT OMNI THROMBECTOMY SET
• Applicant: MEDRAD, INC.; 9055 evergreen blvd nw; minneapolis, MN 55433 8003
• Contact: doug atkins
• Regulation Number: 870.5150
• Classification Product Code: DXE
• Subsequent Product Code: KRA
• Date Received: 04/27/2011
• Decision Date: 05/24/2011
• 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