K171957 is an FDA 510(k) clearance for the MaxZero Extension Sets with Needless Connector. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Carefusion 303, Inc. (San Diego, US). The FDA issued a Cleared decision on July 19, 2017, 20 days after receiving the submission on June 29, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K171957 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2017 |
| Decision Date | July 19, 2017 |
| Days to Decision | 20 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 |