The following data is part of a premarket notification filed by Shanghai Kindly Medical Instruments Co.,ltd. with the FDA for Angiography Syringe.
| Device ID | K170025 |
| 510k Number | K170025 |
| Device Name: | Angiography Syringe |
| Classification | Injector And Syringe, Angiographic |
| Applicant | SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. NO. 925 JINYUAN YI RD Shanghai, CN 201803 |
| Contact | Xu Jianhai |
| Correspondent | Jeffery Hui SHANGHAI KINDLY MEDICAL INSTRUMENTS CO.,LTD. NO. 925 JINYUAN YI RD Shanghai, CN 201803 |
| Product Code | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-03 |
| Decision Date | 2017-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40889942766728 | K170025 | 000 |
| 40193489413411 | K170025 | 000 |
| 26950900920374 | K170025 | 000 |
| 26950900920367 | K170025 | 000 |
| 26950900920350 | K170025 | 000 |
| 26950900920251 | K170025 | 000 |
| 26950900920244 | K170025 | 000 |
| 26950900920237 | K170025 | 000 |
| 26950900920220 | K170025 | 000 |
| 40193489413879 | K170025 | 000 |
| 40193489414067 | K170025 | 000 |
| 40889942596226 | K170025 | 000 |
| 40193489414340 | K170025 | 000 |
| 40193489414319 | K170025 | 000 |
| 40193489414302 | K170025 | 000 |
| 40193489414296 | K170025 | 000 |
| 40193489414241 | K170025 | 000 |
| 40193489414173 | K170025 | 000 |
| 40193489414111 | K170025 | 000 |
| 26950900920213 | K170025 | 000 |