K171132 is an FDA 510(k) clearance for the Carefusion NeutraClear Needle-free connector. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Cair Lgl (Lissieu, FR). The FDA issued a Cleared decision on July 31, 2017, 105 days after receiving the submission on April 17, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K171132 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 2017 |
| Decision Date | July 31, 2017 |
| Days to Decision | 105 days |
| Submission Type | Special |
| 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 |