The following data is part of a premarket notification filed by Lepu Medical Technology (beijing) Co., Ltd. with the FDA for Ultraskin Hydrophilic Guide Wire.
| Device ID | K141707 |
| 510k Number | K141707 |
| Device Name: | ULTRASKIN HYDROPHILIC GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. 1531 FELTON ROAD South Euclid, OH 44121 |
| Contact | Arthur Goddard |
| Correspondent | Arthur Goddard LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. 1531 FELTON ROAD South Euclid, OH 44121 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-24 |
| Decision Date | 2015-01-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00819667020654 | K141707 | 000 |
| 00819667020647 | K141707 | 000 |