K173665 is an FDA 510(k) clearance for the AMSafe Sure-Lok Needle-Free Connector. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Amsino International, Inc. (Pomona, US). The FDA issued a Cleared decision on September 5, 2018, 280 days after receiving the submission on November 29, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K173665 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2017 |
| Decision Date | September 05, 2018 |
| Days to Decision | 280 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 |