Hlic Needle-Less Valve
FDA 510(k) K120548 · Health Line International Corporation
510(k) numberK120548
Submission
- Device name
- Hlic Needle-Less Valve
- Applicant
- Health Line International Corporation
Centerville, UT, US - Received
- February 23, 2012
- Decision date
- May 4, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was Hlic Needle-Less Valve cleared by the FDA?
Hlic Needle-Less Valve (K120548) received a 510(k) decision of Substantially Equivalent on May 4, 2012, 71 days after the submission was received.
What is the product code of K120548?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.