The following data is part of a premarket notification filed by Kai Medtech, Llc with the FDA for Minjie Catheter System.
| Device ID | K212288 |
| 510k Number | K212288 |
| Device Name: | Minjie Catheter System |
| Classification | Catheter, Percutaneous, Neurovasculature |
| Applicant | Kai Medtech, LLC 22651 Lambert Street, Suite 107 Lake Forest, CA 92630 |
| Contact | Stephanie Rallis |
| Correspondent | Ricardo Olivo Kai Medtech, LLC 22651 Lambert Street, Suite 107 Lake Forest, CA 92630 |
| Product Code | QJP |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-07-21 |
| Decision Date | 2022-06-02 |