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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
510(k) Number K071538
Device Name ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER
Applicant
ARROW INTERNATIONAL, INC.
2400 BERNVILLE RD.
PO BOX 12888
READING,  PA  19612 -2888
Applicant Contact KIRSTEN STOWELL
Correspondent
ARROW INTERNATIONAL, INC.
2400 BERNVILLE RD.
PO BOX 12888
READING,  PA  19612 -2888
Correspondent Contact KIRSTEN STOWELL
Regulation Number880.5200
Classification Product Code
FOZ  
Date Received06/05/2007
Decision Date 08/30/2007
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
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