Powerloc Clear Safety Infusion Set
FDA 510(k) K082306 · C.R. Bard, Inc.
510(k) numberK082306
Submission
- Device name
- Powerloc Clear Safety Infusion Set
- Applicant
- C.R. Bard, Inc.
Salt Lake Ciy,, UT, US - Received
- August 13, 2008
- Decision date
- August 28, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Clear Safety Infusion Set cleared by the FDA?
Powerloc Clear Safety Infusion Set (K082306) received a 510(k) decision of Substantially Equivalent on August 28, 2008, 15 days after the submission was received.
What is the product code of K082306?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.