Check Valve, Retrograde Flow (In-Line)
The In-Line Retrograde Flow Check Valve is a one-directional flow control component used in medical fluid administration sets or infusion lines to prevent backflow of fluids toward the patient or the fluid source, maintaining the intended direction of flow during intravenous therapy or other fluid delivery procedures. Classified as a Class 2 device under 21 CFR 880.5440 within the General Hospital specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MJF
- Device Class
- FDA class 2
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K861586 | LOPEZ VALVE | Aug 18, 1986 | Substantially Equivalent | Icu Medical, Inc. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.