The following data is part of a premarket notification filed by Shanghai Kindly Medical Instruments Co.,ltd. with the FDA for Y-connector Kit.
| Device ID | K170024 |
| 510k Number | K170024 |
| Device Name: | Y-Connector Kit |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| 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 | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| 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 |
|---|---|---|
| 00850004162057 | K170024 | 000 |
| 26950900906644 | K170024 | 000 |
| 26950900906651 | K170024 | 000 |
| 26950900906668 | K170024 | 000 |
| 46950900906679 | K170024 | 000 |
| 16950900921701 | K170024 | 000 |
| 26950900921852 | K170024 | 000 |
| 16950900922067 | K170024 | 000 |
| 26950900922217 | K170024 | 000 |
| 16950900922227 | K170024 | 000 |
| 16950900922296 | K170024 | 000 |
| 16950900922357 | K170024 | 000 |
| 26950900923405 | K170024 | 000 |
| 16950900929400 | K170024 | 000 |
| 16950900941396 | K170024 | 000 |
| 16950900965309 | K170024 | 000 |
| 16950900965316 | K170024 | 000 |
| 16950900965323 | K170024 | 000 |
| 26950900906620 | K170024 | 000 |