510(k) Premarket Notification

• Device Classification Name: catheter,intravascular,therapeutic,short-term less than 30 days
• 510(k) Number: K970864
• FOIA Releasable 510(k): K970864
• Device Name: ARROW-HOWES LARGE BORE MULTI-LUMEN CENTRAL VENOUS CATHETERS
• Applicant: ARROW INTL., INC.; 3000 bernville rd.; reading, PA 19605
• Applicant Contact: thomas d nickel
• Correspondent: ARROW INTL., INC.; 3000 bernville rd.; reading, PA 19605
• Correspondent Contact: thomas d nickel
• Regulation Number: 880.5200
• Classification Product Code: FOZ
• Date Received: 03/10/1997
• Decision Date: 10/17/1997
• Decision: substantially equivalent (SESE)
• Regulation Medical Specialty: General Hospital
• 510k Review Panel: General Hospital
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No
• Recalls: CDRH Recalls