Non-Dehp Micro-Volume Extension Set with 0.22 Micron Filter
FDA 510(k) K113227 · Baxter Healthcare Corp
510(k) numberK113227
Submission
- Device name
- Non-Dehp Micro-Volume Extension Set with 0.22 Micron Filter
- Applicant
- Baxter Healthcare Corp
Deerfield, IL, US - Received
- November 1, 2011
- Decision date
- December 8, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPB – Filter, Infusion Line
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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Questions and answers
When was Non-Dehp Micro-Volume Extension Set with 0.22 Micron Filter cleared by the FDA?
Non-Dehp Micro-Volume Extension Set with 0.22 Micron Filter (K113227) received a 510(k) decision of Substantially Equivalent on December 8, 2011, 37 days after the submission was received.
What is the product code of K113227?
The FDA product code is FPB – Filter, Infusion Line, a Class II (moderate risk) device regulated under 21 CFR 880.5440.