BioFlo Midline Catheter— 510(k) K161866
Substantially EquivalentNavilyst Medical, Inc.
FDA 510(k) clearance K161866 for BioFlo Midline Catheter, Substantially Equivalent on 2016-09-08. Applicant: Navilyst Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Navilyst Medical, Inc.
- Product code
- Code FOZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5200
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlborough, MA, US
Recent devices under product code FOZ
view allMore clearances from Navilyst Medical, Inc.
view all- K163452 — PICC Maximal Barrier Nursing Kit
- K151239 — NMI DUAL PORT II
- K153228 — NMI Port, NMI Port II
- K152069 — Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter
- K152409 — Xcela PICC with PASV, Xcela Hybrid PICC with PASV, Xcela Power Injectable PICC
Adverse events under product code FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K161866
K-number listed on FDA's recall record- Z-2198-2018 — BioFlo Midline 5F DL-20cm Max Sterile Barrier Drape Kit w/ Two Nitinol Guidewire PG, Catalog Number 46-490
- Z-2199-2018 — BioFlo Midline 5F DL-20cm MST-45 Kit w/ Two Nitinol Guidewires PG, Catalog Number 46-810
- Z-2202-2018 — RS - TANDEM 5F DL BIOFLO MIDLINE, Catalog Number 60M035472
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161866.
Data sourced from openFDA. This site is unofficial and independent of the FDA.