The following data is part of a premarket notification filed by Anhui Kangda Medical Products Co., Ltd. with the FDA for Baixin Intravascular Administration Set.
| Device ID | K083687 |
| 510k Number | K083687 |
| Device Name: | BAIXIN INTRAVASCULAR ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | ANHUI KANGDA MEDICAL PRODUCTS CO., LTD. 1707 YINQIAO BLDG. 58 JINXIN RD., JINQIAO Pudong, Shanghai, CN 201206 |
| Contact | Bian Wei Qiang |
| Correspondent | Bian Wei Qiang ANHUI KANGDA MEDICAL PRODUCTS CO., LTD. 1707 YINQIAO BLDG. 58 JINXIN RD., JINQIAO Pudong, Shanghai, CN 201206 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-12 |
| Decision Date | 2009-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616787704729 | K083687 | 000 |
| 00819667020173 | K083687 | 000 |
| 00819667020180 | K083687 | 000 |
| 00616784703824 | K083687 | 000 |
| 00616784703923 | K083687 | 000 |
| 00616784704029 | K083687 | 000 |
| 00616784704128 | K083687 | 000 |
| 00616784704227 | K083687 | 000 |
| 00616784704326 | K083687 | 000 |
| 00616784704425 | K083687 | 000 |
| 00616784704524 | K083687 | 000 |
| 00616784704623 | K083687 | 000 |
| 00616784706412 | K083687 | 000 |
| 00616784706511 | K083687 | 000 |
| 10819667020163 | K083687 | 000 |