K140831 is an FDA 510(k) clearance for the MAXZERO EXTENSION SET WITH NEEDLESS CONNECTOR. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Care Fusion (San Diego, US). The FDA issued a Cleared decision on April 15, 2014, 13 days after receiving the submission on April 2, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K140831 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 02, 2014 |
| Decision Date | April 15, 2014 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |