The following data is part of a premarket notification filed by Shanghai Kindly Medical Instruments Co., Ltd. with the FDA for Introducer Set.
| Device ID | K180178 |
| 510k Number | K180178 |
| Device Name: | Introducer Set |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-22 |
| Decision Date | 2018-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850004162200 | K180178 | 000 |
| 26950900923733 | K180178 | 000 |
| 26950900923719 | K180178 | 000 |
| 26950900923696 | K180178 | 000 |
| 26950900923542 | K180178 | 000 |
| 26950900923061 | K180178 | 000 |
| 26950900921142 | K180178 | 000 |
| 26950900921135 | K180178 | 000 |
| 26950900921128 | K180178 | 000 |
| 26950900921111 | K180178 | 000 |
| 26950900920565 | K180178 | 000 |
| 26950900920312 | K180178 | 000 |
| 26950900920305 | K180178 | 000 |
| 26950900926291 | K180178 | 000 |
| 26950900926314 | K180178 | 000 |
| 26950900926338 | K180178 | 000 |
| 00850004162194 | K180178 | 000 |
| 00850004162187 | K180178 | 000 |
| 00850004162170 | K180178 | 000 |
| 00850004162163 | K180178 | 000 |
| 00850004162156 | K180178 | 000 |
| 00850004162149 | K180178 | 000 |
| 00850004162132 | K180178 | 000 |
| 00850004162125 | K180178 | 000 |
| 26950900961582 | K180178 | 000 |
| 26950900926390 | K180178 | 000 |
| 26950900926376 | K180178 | 000 |
| 26950900926352 | K180178 | 000 |
| 06950900920295 | K180178 | 000 |