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510(k) K140266

NMI PICC IV by Navilyst Medical, Inc. — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2014
Date Received
February 3, 2014
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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  • K150527 — Xcela Power Injectable PICC (March 31, 2015)
  • K150448 — NMI PICC III and NMI PICC IV (March 19, 2015)
  • K142616 — PICC Maximal Barrier Nursing Kit (October 14, 2014)

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