Maxzero Extension Set with Needless Connector
FDA 510(k) K140831 · Care Fusion
510(k) numberK140831
Submission
- Device name
- Maxzero Extension Set with Needless Connector
- Applicant
- Care Fusion
San Diego, CA, US - Received
- April 2, 2014
- Decision date
- April 15, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 Maxzero Extension Set with Needless Connector cleared by the FDA?
Maxzero Extension Set with Needless Connector (K140831) received a 510(k) decision of Substantially Equivalent on April 15, 2014, 13 days after the submission was received.
What is the product code of K140831?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.