The following data is part of a premarket notification filed by Jiangxi Yikang Medical Instrument Group Co., Ltd. with the FDA for Yikang Latex Foley Catheter.
| Device ID | K173340 |
| 510k Number | K173340 |
| Device Name: | Yikang Latex Foley Catheter |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | Jiangxi Yikang Medical Instrument Group Co., LTD. No.188 LiduAihua Ave., Jinxian County Nanchang, CN 331725 |
| Contact | Nicholas Su |
| Correspondent | Nicholas Su Jiangxi Yikang Medical Instrument Group Co., LTD. No.188 LiduAihua Ave., Jinxian County Nanchang, CN 331725 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-23 |
| Decision Date | 2018-07-13 |
| Summary: | summary |