Nipro Huber Infusion Set, Excel Huber Infusion Set
FDA 510(k) K113471 · Nipro Medical Corporation
510(k) numberK113471
Submission
- Device name
- Nipro Huber Infusion Set, Excel Huber Infusion Set
- Applicant
- Nipro Medical Corporation
Miami, FL, US - Received
- November 22, 2011
- Decision date
- October 18, 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 Nipro Huber Infusion Set, Excel Huber Infusion Set cleared by the FDA?
Nipro Huber Infusion Set, Excel Huber Infusion Set (K113471) received a 510(k) decision of Substantially Equivalent on October 18, 2012, 331 days after the submission was received.
What is the product code of K113471?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.