The following data is part of a premarket notification filed by Shanghai Microport Ep Medtech Co., Ltd. with the FDA for Pathbuilder Transseptal Needle.
| Device ID | K212625 |
| 510k Number | K212625 |
| Device Name: | PathBuilder Transseptal Needle |
| Classification | Trocar |
| Applicant | Shanghai MicroPort EP MedTech Co., Ltd. Building 23&28, Lane 588, Tianxiong Rd. Shanghai, CN |
| Contact | Tian Xia |
| Correspondent | Tian Xia Shanghai MicroPort EP MedTech Co., Ltd. Building 23&28, Lane 588, Tianxiong Rd. Shanghai, CN |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-18 |
| Decision Date | 2022-03-23 |