The following data is part of a premarket notification filed by Hangzhou Ags Medtech Co., Ltd. with the FDA for Stone Retrieval Balloon.
| Device ID | K200173 |
| 510k Number | K200173 |
| Device Name: | Stone Retrieval Balloon |
| Classification | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Applicant | Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou, CN 311106 |
| Contact | Chunqi Han |
| Correspondent | Chunqi Han Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou, CN 311106 |
| Product Code | GCA |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-23 |
| Decision Date | 2020-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16959664910754 | K200173 | 000 |
| 16959664910747 | K200173 | 000 |
| 16959664910716 | K200173 | 000 |
| 16959664910709 | K200173 | 000 |