The following data is part of a premarket notification filed by Shanghai Kindly Medical Instruments Co., Ltd. with the FDA for Kdl Micro Catheter.
| Device ID | K201706 |
| 510k Number | K201706 |
| Device Name: | KDL Micro Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Shanghai Kindly Medical Instruments Co., Ltd. No. 925, Jinyuan Yi Road Shanghai, CN 201803 |
| Contact | Xu Jianhai |
| Correspondent | Xu Jianhai Shanghai Kindly Medical Instruments Co., Ltd. No. 925, Jinyuan Yi Road Shanghai, CN 201803 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-22 |
| Decision Date | 2021-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26950900998939 | K201706 | 000 |
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