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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 K130876
Device Name CG+ ARROW PICC POWERED BY ARROW VPS STYLET
Applicant
Arrow International, Inc.
2400 Bernville Rd.
Reading,  PA  19605
Applicant Contact ELIZABETH DUNCAN
Correspondent
Arrow International, Inc.
2400 Bernville Rd.
Reading,  PA  19605
Correspondent Contact ELIZABETH DUNCAN
Regulation Number880.5970
Classification Product Code
LJS  
Date Received03/29/2013
Decision Date 04/26/2013
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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