K171117 is an FDA 510(k) clearance for the Carefusion NeutraClear Needle-free connector (EL-NC1000). 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 September 1, 2017, 140 days after receiving the submission on April 14, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K171117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2017 |
| Decision Date | September 01, 2017 |
| Days to Decision | 140 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 |