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510(k) K163452

PICC Maximal Barrier Nursing Kit by Navilyst Medical, Inc. — Product Code LJS

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
February 3, 2017
Date Received
December 9, 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

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  • K150448 — NMI PICC III and NMI PICC IV (March 19, 2015)
  • K142616 — PICC Maximal Barrier Nursing Kit (October 14, 2014)
  • K140194 — NAMIC RCS SYRINGE (April 14, 2014)

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