510(k) Premarket Notification

• Device Classification Name: catheter, intravascular, diagnostic
• 510(K) Number: K911957
• Device Name: ACS RX SUPPORT CATHETER
• Applicant: ADVANCED CARDIOVASCULAR SYSTEMS, INC.; 26531 ynez rd.; temecula, CA 92591
• Contact: kevin corrigan
• Regulation Number: 870.1200
• Classification Product Code: DQO
• Date Received: 05/02/1991
• Decision Date: 09/06/1991
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Cardiovascular
• Review Advisory Committee: Cardiovascular
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No