K143446 is an FDA 510(k) clearance for the Accu-Chek FlexLink Plus infusion set. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Roche Diagnostics GmbH (Mannheim, DE). The FDA issued a Cleared decision on August 13, 2015, 254 days after receiving the submission on December 2, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K143446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2014 |
| Decision Date | August 13, 2015 |
| Days to Decision | 254 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 |