The following data is part of a premarket notification filed by Lepu Medical Technology (beijing) Co., Ltd. with the FDA for Type I, Type Ii, Type Iii, Type Iv.
| Device ID | K172331 |
| 510k Number | K172331 |
| Device Name: | Type I, Type II, Type III, Type IV |
| Classification | Introducer, Catheter |
| Applicant | Lepu Medical Technology (Beijing) Co., Ltd. No. 37 Chaoqian Road Beijing, CN 102200 |
| Contact | Xiangdan Jin |
| Correspondent | Arthur Goddard FDA Regulatory And Quality Systems Consultant 31853 Cedar Road Mayfield Heights, OH 44124 -4445 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-02 |
| Decision Date | 2018-03-02 |
| Summary: | summary |