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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 K161765
Device Name CG+ Arrow JACC
Applicant
Arrow International, Inc. (Subsidiary of Teleflex
2400 Bernville Rd.
Reading,  PA  19605
Applicant Contact JULIE LAWSON
Correspondent
Arrow International, Inc. (Subsidiary of Teleflex
2400 Bernville Rd.
Reading,  PA  19605
Correspondent Contact JULIE LAWSON
Regulation Number880.5970
Classification Product Code
LJS  
Date Received06/27/2016
Decision Date 09/06/2016
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
Predetermined Change
Control Plan Authorized		 No
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