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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 K153487
Device Name CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS
Applicant
ARROW INTERNATIONAL, INC. (Subsidiary of Teleflex Inc.)
2400 BERNVILLE ROAD
READING,  PA  19605
Applicant Contact Elizabeth Duncan
Correspondent
ARROW INTERNATIONAL, INC. (Subsidiary of Teleflex Inc.)
2400 BERNVILLE ROAD
READING,  PA  19605
Correspondent Contact Elizabeth Duncan
Regulation Number880.5970
Classification Product Code
LJS  
Subsequent Product Code
OBJ  
Date Received12/04/2015
Decision Date 02/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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