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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, Long-Term Greater Than 30 Days
510(k) Number K930129
Device Name ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER
Applicant
ARROW INTL., INC.
P.O. BOX 12888
3000 BERNVILLE RD
READING,  PA  19612
Applicant Contact THOMAS D NICKEL
Correspondent
ARROW INTL., INC.
P.O. BOX 12888
3000 BERNVILLE RD
READING,  PA  19612
Correspondent Contact THOMAS D NICKEL
Regulation Number880.5970
Classification Product Code
LJS  
Date Received01/12/1993
Decision Date 03/28/1994
Decision Substantially Equivalent - Kit With Drugs (SEKD)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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