510(k) Premarket Notification

• Device Classification Name: catheter, intravascular, diagnostic
• 510(K) Number: K911605
• Device Name: TRACKER UNIBODY, UNIBODY W/SIDE & 25 SIDE HOLES
• Applicant: TARGET THERAPEUTICS; 130 rio robles; p.o. box 610458; san jose, CA 95134
• Contact: alexis ball
• Regulation Number: 870.1200
• Classification Product Code: DQO
• Date Received: 04/10/1991
• Decision Date: 07/09/1991
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Cardiovascular
• Review Advisory Committee: Cardiovascular
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No