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510(k) K161765

CG+ Arrow JACC by Arrow International, Inc. (Subsidiary of Teleflex — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2016
Date Received
June 27, 2016
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

Other clearances by Arrow International, Inc. (Subsidiary of Teleflex

  • K123759 — CG+ ARROW PICC POWERED BY ARROW VPS STYLET (January 3, 2013)

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