K160648 is an FDA 510(k) clearance for the MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Unomedical A/S (Osted, DK). The FDA issued a Cleared decision on August 10, 2016, 156 days after receiving the submission on March 7, 2016.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K160648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2016 |
| Decision Date | August 10, 2016 |
| Days to Decision | 156 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 |