K163141 is an FDA 510(k) clearance for the NAMIC ClearaCIL Contrast Injection Lines. This device is classified as a Catheter, Intravascular, Diagnostic (Class II - Special Controls, product code DQO).
Submitted by AngioDynamics, Inc. (Glens Falls, US). The FDA issued a Cleared decision on January 6, 2017, 58 days after receiving the submission on November 9, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200.
| 510(k) Number | K163141 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2016 |
| Decision Date | January 06, 2017 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQO — Catheter, Intravascular, Diagnostic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |