FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
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)
K Number: K244059
·
Decision Mar 27, 2025
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
9
Review Days
86
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Basic Information
- Device Name
- 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)
- K Number
- K244059
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Access Vascular, Inc.
- Date Received
- December 31, 2024
- Decision Date
- March 27, 2025
- Product Code
- FOZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
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Other Clearances by Access Vascular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243458 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302); HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304); HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301); HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302); HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304); Hydr | Aug 1, 2025 | Substantially Equivalent |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) | Jul 1, 2025 | Substantially Equivalent |
| K243941 | HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204) | Jan 17, 2025 | Substantially Equivalent |
| K220772 | HydroMID 4F Single Lumen Midline Catheter | Dec 7, 2022 | Substantially Equivalent |
| K213550 | HydroPICC 5F Dual Lumen Catheter | May 4, 2022 | Substantially Equivalent |
| K203069 | HydroMID | Feb 8, 2021 | Substantially Equivalent |
| K193015 | HydroPICC (PICC-142) | Feb 20, 2020 | Substantially Equivalent |
| K172885 | HydroPICC | Feb 20, 2018 | Substantially Equivalent |