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510(k) K150407

BioFlo Midline Catheter by Navilyst Medical, Inc. — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2015
Date Received
February 18, 2015
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type

Other clearances by Navilyst Medical, Inc.

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  • K153228 — NMI Port, NMI Port II (December 4, 2015)
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  • K152409 — Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC (September 24, 2015)
  • 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)
  • K140194 — NAMIC RCS SYRINGE (April 14, 2014)

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