HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102) +2 more— 510(k) K244059
Substantially EquivalentAccess Vascular, Inc.
FDA 510(k) clearance K244059 for HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102) +2 more, Substantially Equivalent on 2025-03-27. Applicant: Access Vascular, Inc.. Device class: 2.
Clearance details
- Device name as filed
- HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102); HydroMID 5F Dual Lumen Midline Catheter - Max Barrier Kit (70006104); HydroMID 5F Dual Lumen Midline Catheter - Mobile Max Barrier Kit (90006104)
- Applicant
- Access Vascular, 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
- Special
- Location
- Billerica, MD, US
Recent devices under product code FOZ
view allMore clearances from Access Vascular, Inc.
view all- K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301) +5 more
- K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
- K243941 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201) +3 more
- K220772 — HydroMID 4F Single Lumen Midline Catheter
- K213550 — HydroPICC 5F Dual Lumen Catheter
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.