510(k) Premarket Notification

• Device Classification Name: filter, intravascular, cardiovascular
• 510(K) Number: K081138
• Device Name: SAFEFLO VENA CAVA FILTER
• Applicant: RMT MEDICAL TECHNILOGIES INC.; 1835 market street; suite 200; philadelphia, PA 19103
• Contact: janice m hogan
• Regulation Number: 870.3375
• Classification Product Code: DTK
• Date Received: 04/21/2008
• Decision Date: 05/07/2009
• Decision: substantially equivalent - with limitations (SU)
• Classification Advisory Committee: Cardiovascular
• Review Advisory Committee: Cardiovascular
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No