The following data is part of a premarket notification filed by Lepu Medical Technology (bejing) Co., Ltd. with the FDA for Type I Brilliant Introducer Kit, Type Ii Brilliant Introducer Kit, Type Iii Brilliant Introducer Kit, Type Iv Brilliant.
| Device ID | K140768 |
| 510k Number | K140768 |
| Device Name: | TYPE I BRILLIANT INTRODUCER KIT, TYPE II BRILLIANT INTRODUCER KIT, TYPE III BRILLIANT INTRODUCER KIT, TYPE IV BRILLIANT |
| Classification | Introducer, Catheter |
| Applicant | LEPU MEDICAL TECHNOLOGY (BEJING) CO., LTD. 1531 FELTON ROAD South Euclid, OH 44121 |
| Contact | Arthur Goddard |
| Correspondent | Arthur Goddard LEPU MEDICAL TECHNOLOGY (BEJING) CO., LTD. 1531 FELTON ROAD South Euclid, OH 44121 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-27 |
| Decision Date | 2014-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M20690290 | K140768 | 000 |
| M20690130 | K140768 | 000 |
| M20690120 | K140768 | 000 |
| M20690110 | K140768 | 000 |
| M20690020 | K140768 | 000 |
| M20690010 | K140768 | 000 |
| M20690000 | K140768 | 000 |
| M20689990 | K140768 | 000 |
| M20689980 | K140768 | 000 |
| M20689970 | K140768 | 000 |
| M20689960 | K140768 | 000 |
| M20689950 | K140768 | 000 |
| M20690140 | K140768 | 000 |
| M20690150 | K140768 | 000 |
| M20690160 | K140768 | 000 |
| M20690280 | K140768 | 000 |
| M20690270 | K140768 | 000 |
| M20690260 | K140768 | 000 |
| M20690250 | K140768 | 000 |
| M20690240 | K140768 | 000 |
| M20690230 | K140768 | 000 |
| M20690220 | K140768 | 000 |
| M20690210 | K140768 | 000 |
| M20690190 | K140768 | 000 |
| M20690180 | K140768 | 000 |
| M20690170 | K140768 | 000 |
| M20689940 | K140768 | 000 |