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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name midline catheter
510(k) Number K161313
Device Name ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology
Applicant
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.)
2400 BERNVILLE ROAD
READING,  PA  19605
Applicant Contact JULIE LAWSON
Correspondent
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.)
2400 BERNVILLE ROAD
READING,  PA  19605
Correspondent Contact JULIE LAWSON
Regulation Number880.5200
Classification Product Code
PND  
Date Received05/10/2016
Decision Date 08/24/2016
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
Recalls CDRH Recalls
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