510(k) Premarket Notification

• Device Classification Name: catheter, intravascular, diagnostic
• 510(K) Number: K093004
• Device Name: IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING
• Applicant: MERIT MEDICAL SYSTEMS, INC.; 1600 west merit pkwy.; south jordan, UT 84095
• Contact: michaela rivkowich
• Regulation Number: 870.1200
• Classification Product Code: DQO
• Date Received: 09/28/2009
• Decision Date: 02/12/2010
• 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