510(k) Premarket Notification

• Device Classification Name: catheter and tip, suction
• 510(k) Number: K870572
• Device Name: ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT
• Applicant: ARROW INTL., INC.; P.O. BOX 6306; HILL AND GEORGE AVENUES; READING, PA 19610
• Applicant Contact: THOMAS D NICKEL
• Correspondent: ARROW INTL., INC.; P.O. BOX 6306; HILL AND GEORGE AVENUES; READING, PA 19610
• Correspondent Contact: THOMAS D NICKEL
• Regulation Number: 880.6740
• Classification Product Code: JOL
• Date Received: 02/10/1987
• Decision Date: 05/26/1987
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: General Hospital
• 510k Review Panel: General Hospital
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No
• Recalls: CDRH Recalls