The following data is part of a premarket notification filed by Haolang Medical Usa Corporation with the FDA for Umbilical Vessels Catheter.
| Device ID | K201697 |
| 510k Number | K201697 |
| Device Name: | Umbilical Vessels Catheter |
| Classification | Catheter, Umbilical Artery |
| Applicant | Haolang Medical USA Corporation 1100 Bellevue Way NE 8A-533 Bellevue, WA 98004 |
| Contact | Lisa Xu |
| Correspondent | Field Fu Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Bloack A, Zhongguan Times Square, Xili Town Shenzhen, CN 518000 |
| Product Code | FOS |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-22 |
| Decision Date | 2021-05-06 |