K150921 is an FDA 510(k) clearance for the Orbit Infusion Set. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Ypsomed AG (Burgdorf, CH). The FDA issued a Cleared decision on April 12, 2016, 372 days after receiving the submission on April 6, 2015.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K150921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2015 |
| Decision Date | April 12, 2016 |
| Days to Decision | 372 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 |