K160448 is an FDA 510(k) clearance for the ARTLINE. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Health Line International Corporation (Salt Lake City, US). The FDA issued a Cleared decision on July 12, 2016, 145 days after receiving the submission on February 18, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K160448 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 18, 2016 |
| Decision Date | July 12, 2016 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY - Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |