K201697 is an FDA 510(k) clearance for the Umbilical Vessels Catheter. This device is classified as a Catheter, Umbilical Artery (Class II - Special Controls, product code FOS).
Submitted by Haolang Medical USA Corporation (Bellevue, US). The FDA issued a Cleared decision on May 6, 2021, 318 days after receiving the submission on June 22, 2020.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5200.
| 510(k) Number | K201697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2020 |
| Decision Date | May 06, 2021 |
| Days to Decision | 318 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOS - Catheter, Umbilical Artery |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5200 |