PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
FDA 510(k) K153440 · C.R. Bard, Inc.
510(k) numberK153440
Submission
- Device name
- PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
- Applicant
- C.R. Bard, Inc.
Salt Lake Ciy,, UT, US - Received
- November 27, 2015
- Decision date
- August 18, 2016
- 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 PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set cleared by the FDA?
PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set (K153440) received a 510(k) decision of Substantially Equivalent on August 18, 2016, 265 days after the submission was received.
What is the product code of K153440?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.