The following data is part of a premarket notification filed by Hangzhou Ags Medtech Co., Ltd. with the FDA for Balloon Dilatation Catheter.
| Device ID | K213578 |
| 510k Number | K213578 |
| Device Name: | Balloon Dilatation Catheter |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou, CN 311106 |
| Contact | Jiayuan Zhang |
| Correspondent | Jiayuan Zhang Hangzhou AGS MedTech Co., Ltd. Building 5, Building 6, No.597 Kangxin Road Yuhang District Hangzhou, CN 311106 |
| Product Code | FDF |
| Subsequent Product Code | FDS |
| Subsequent Product Code | KNQ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-10 |
| Decision Date | 2022-04-06 |