The following data is part of a premarket notification filed by Anhui Tiankang Medical Technology Co.,ltd. with the FDA for Tk Intravascular Administration Set.
| Device ID | K191640 |
| 510k Number | K191640 |
| Device Name: | TK Intravascular Administration Set |
| Classification | Set, Administration, Intravascular |
| Applicant | Anhui Tiankang Medical Technology Co.,Ltd. No.228 Weiyi Road, Economic Development Zone Tianchang, CN 239300 |
| Contact | Bai Baodong |
| Correspondent | Bai Baodong Anhui Tiankang Medical Technology Co.,Ltd. No.228 Weiyi Road, Economic Development Zone Tianchang, CN 239300 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-19 |
| Decision Date | 2020-08-26 |