HydroMID— 510(k) K203069
Substantially EquivalentAccess Vascular, Inc.
FDA 510(k) clearance K203069 for HydroMID, Substantially Equivalent on 2021-02-08. Applicant: Access Vascular, Inc.. Device class: 2.
Clearance details
- 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
- Abbreviated
- Location
- Bedford, MA, 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)
- K244059 — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102) +2 more
- K243941 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201) +3 more
- K220772 — HydroMID 4F Single Lumen Midline 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 →
Recalls naming K203069
K-number listed on FDA's recall record- Z-1155-2023 — HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Model Number: 80004004
- Z-1156-2023 — HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy Product Number: 80004004
- Z-1129-2023 — HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K203069.
Data sourced from openFDA. This site is unofficial and independent of the FDA.