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510(k) K150448

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2015
Date Received
February 20, 2015
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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  • K152409 — Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC (September 24, 2015)
  • K150407 — BioFlo Midline Catheter (May 15, 2015)
  • K150527 — Xcela Power Injectable PICC (March 31, 2015)
  • K142616 — PICC Maximal Barrier Nursing Kit (October 14, 2014)
  • K140194 — NAMIC RCS SYRINGE (April 14, 2014)

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