The following data is part of a premarket notification filed by Medcaptain Life Science Co., Ltd. with the FDA for Kardiflex Nc Coronary Dilatation Catheter.
| Device ID | K202578 |
| 510k Number | K202578 |
| Device Name: | KardiFlex NC Coronary Dilatation Catheter |
| Classification | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | Medcaptain Life Science Co., Ltd. 601, Building C, Jinweiyuan Industrial Park, Pingshan District Shenzhen, CN 518118 |
| Contact | David Xia |
| Correspondent | David Xia Medcaptain Life Science Co., Ltd. 601, Building C, Jinweiyuan Industrial Park, Pingshan District Shenzhen, CN 518118 |
| Product Code | LOX |
| CFR Regulation Number | 870.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-08 |
| Decision Date | 2021-05-06 |