K193088 is an FDA 510(k) clearance for the MaxZero Extension Sets with Needle-Free Connector(s). This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Carefusion, Inc. (Brea, US). The FDA issued a Cleared decision on October 23, 2020, 352 days after receiving the submission on November 6, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K193088 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 06, 2019 |
| Decision Date | October 23, 2020 |
| Days to Decision | 352 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 |