HydroMID
FDA 510(k) clearance K203069 · decided 2021-02-08
Clearance details
- K-number
- K203069
- Device name
- HydroMID
- Applicant
- Access Vascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-10-09
- Decision date
- 2021-02-08
- Days to decision
- 122 days
- Clearance type
- Abbreviated
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HydroMID 4Fr Single Lumen Maximal Barrier Kit- Indicated for short term access (<30days) t recall (Z-1155-2023) | Access Vascular, Inc | 2023-02-22 |
| HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to recall (Z-1156-2023) | Access Vascular, Inc | 2023-02-22 |
| HydroMID 4Fr Single Lumen - Basic Kit, Model Number 80004002 recall (Z-1129-2023) | Access Vascular, Inc | 2023-02-10 |