IV Decanter-Flexible
FDA 510(k) K980587 · Inrad
510(k) numberK980587
Submission
- Device name
- IV Decanter-Flexible
- Applicant
- Inrad
Kentwood, MI, US - Received
- February 17, 1998
- Decision date
- April 17, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LHI – Set, I.V. Fluid Transfer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was IV Decanter-Flexible cleared by the FDA?
IV Decanter-Flexible (K980587) received a 510(k) decision of Substantially Equivalent on April 17, 1998, 59 days after the submission was received.
What is the product code of K980587?
The FDA product code is LHI – Set, I.V. Fluid Transfer, a Class II (moderate risk) device regulated under 21 CFR 880.5440.