The following data is part of a premarket notification filed by Lepu Medical Technology (beijing) Co., Ltd with the FDA for Vasc Band Hemostat.
| Device ID | K142359 |
| 510k Number | K142359 |
| Device Name: | Vasc Band Hemostat |
| Classification | Clamp, Vascular |
| Applicant | Lepu Medical Technology (Beijing) Co., LTD No. 37 Chaoqian Road Beijing, CN 102200 |
| Contact | Kim Xiangdan |
| Correspondent | Erin Badali Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-25 |
| Decision Date | 2014-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10819667020866 | K142359 | 000 |
| 10819667020804 | K142359 | 000 |
| 10819667020798 | K142359 | 000 |
| 10819667020781 | K142359 | 000 |