The following data is part of a premarket notification filed by Shanghai Heartcare Medical Technology Co., Ltd with the FDA for Balloon Guiding Catheter.
| Device ID | K202916 |
| 510k Number | K202916 |
| Device Name: | Balloon Guiding Catheter |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | Shanghai Heartcare Medical Technology Co., Ltd 590 Ruiqing Rd, Building 4, Suite 201, East Zhangjiang High-Tech Park Shanghai, CN 201201 |
| Contact | Zongyu Xue |
| Correspondent | Tingting Su Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | QJP |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-29 |
| Decision Date | 2021-08-25 |