K212625 is an FDA 510(k) clearance for the PathBuilder Transseptal Needle. This device is classified as a Trocar (Class II - Special Controls, product code DRC).
Submitted by Shanghai Microport EP Medtech Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 23, 2022, 217 days after receiving the submission on August 18, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1390.
| 510(k) Number | K212625 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2021 |
| Decision Date | March 23, 2022 |
| Days to Decision | 217 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRC - Trocar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1390 |