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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 K100635
FOIA Releasable 510(k) K100635
Device Name ARROWGARD EVOLUTION ANTIMICROBIAL PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) MODEL: S-44041-002, S-45041-002, S-45504
Applicant
ARROW INTL., INC.
2400 BERNVILLE RD.
READING,  PA  19605
Applicant Contact TRACY MADDOCK
Correspondent
ARROW INTL., INC.
2400 BERNVILLE RD.
READING,  PA  19605
Correspondent Contact TRACY MADDOCK
Regulation Number880.5970
Classification Product Code
LJS  
Date Received03/05/2010
Decision Date 08/27/2010
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 Yes
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