Cleared Traditional

BioFlo Midline Catheter

K161866 · Navilyst Medical, Inc. · General Hospital
Sep 2016
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K161866 is an FDA 510(k) clearance for the BioFlo Midline Catheter, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Navilyst Medical, Inc. (Marlborough, US). The FDA issued a Cleared decision on September 8, 2016, 63 days after receiving the submission on July 7, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K161866 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2016
Decision Date September 08, 2016
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5200

Similar Devices — FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 500
SURFLO Hybria Closed System Safety IV Catheter
K252398 · Terumo Medical Products Hangzhou Co., Ltd. · Dec 2025
Polyshield Safety IV Catheters
K252677 · Poly Medicure Limited · Nov 2025
BD Saf-T-Intima? Subcutaneous Catheter System
K251422 · Becton Dickinson Infusion Therapy Systems, Inc. · Oct 2025
BD Nexiva? Closed IV Catheter System
K243403 · Becton Dickinson Infusion Therapy Systems, Inc. · Jul 2025
BD Cathena? Safety IV Catheter
K251155 · Becton Dickinson Infusion Therapy Systems, Inc. · Jul 2025
BD Insyte? Autoguard? Shielded IV Catheter, BD Insyte? Autoguard? BC Shielded IV Catheter and BD Insyte? Autoguard? BC Pro Shielded IV Catheter
K251654 · Becton Dickinson Infusion Therapy Systems, Inc. · Jun 2025