The following data is part of a premarket notification filed by Shanghai Microport Ep Medtech Co., Ltd. with the FDA for Pathbuilder Transseptal Guiding Introducer.
| Device ID | K212626 |
| 510k Number | K212626 |
| Device Name: | PathBuilder Transseptal Guiding Introducer |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-18 |
| Decision Date | 2022-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06952450957202 | K212626 | 000 |
| 06952450956922 | K212626 | 000 |
| 06952450956939 | K212626 | 000 |
| 06952450956946 | K212626 | 000 |
| 06952450956953 | K212626 | 000 |
| 06952450956960 | K212626 | 000 |
| 06952450956977 | K212626 | 000 |
| 06952450956984 | K212626 | 000 |
| 06952450956991 | K212626 | 000 |
| 06952450956915 | K212626 | 000 |
| 06952450956908 | K212626 | 000 |
| 06952450948101 | K212626 | 000 |
| 06952450948118 | K212626 | 000 |
| 06952450948125 | K212626 | 000 |
| 06952450948132 | K212626 | 000 |
| 06952450948149 | K212626 | 000 |
| 06952450956878 | K212626 | 000 |
| 06952450956885 | K212626 | 000 |
| 06952450956892 | K212626 | 000 |
| 06952450957004 | K212626 | 000 |
| 06952450957011 | K212626 | 000 |
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| 06952450957134 | K212626 | 000 |
| 06952450957141 | K212626 | 000 |
| 06952450957158 | K212626 | 000 |
| 06952450957165 | K212626 | 000 |
| 06952450957172 | K212626 | 000 |
| 06952450957189 | K212626 | 000 |
| 06952450957196 | K212626 | 000 |
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| 06952450957103 | K212626 | 000 |
| 06952450957028 | K212626 | 000 |
| 06952450957035 | K212626 | 000 |
| 06952450957042 | K212626 | 000 |
| 06952450957059 | K212626 | 000 |
| 06952450957066 | K212626 | 000 |
| 06952450957073 | K212626 | 000 |
| 06952450957080 | K212626 | 000 |
| 06952450957097 | K212626 | 000 |
| 06952450948095 | K212626 | 000 |