510(k) Premarket Notification

• Device Classification Name: introducer, catheter
• 510(k) Number: K002507
• Device Name: TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT
• Applicant: ARROW INTL., INC.; 2400 bernville rd.; reading, PA 19605
• Applicant Contact: thomas d nickel
• Correspondent: ARROW INTL., INC.; 2400 bernville rd.; reading, PA 19605
• Correspondent Contact: thomas d nickel
• Regulation Number: 870.1340
• Classification Product Code: DYB
• Subsequent Product Code: FOZ
• Date Received: 08/15/2000
• Decision Date: 03/21/2001
• Decision: substantially equivalent (SESE)
• Regulation Medical Specialty: Cardiovascular
• 510k Review Panel: General Hospital
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No
• Recalls: CDRH Recalls