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510(k) K161866

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 2016
Date Received
July 7, 2016
Clearance Type
Traditional
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

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  • K142616 — PICC Maximal Barrier Nursing Kit (October 14, 2014)
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