The following data is part of a premarket notification filed by Haolang Medical Usa Corporation with the FDA for Arterial Catheter.
| Device ID | K201726 |
| 510k Number | K201726 |
| Device Name: | Arterial Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Haolang Medical USA Corporation 1100 Bellevue Way NE 8A-533 Bellevue, WA 98004 |
| Contact | Lisa Xu |
| Correspondent | Lisa Xu Haolang Medical USA Corporation 1100 Bellevue Way NE 8A-533 Bellevue, WA 98004 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-23 |
| Decision Date | 2021-07-07 |