510(k) K212626 ยท DYB Introducer, Catheter
PathBuilder Transseptal Guiding Introducer
| Applicant | Shanghai Microport EP Medtech Co., Ltd., Shanghai, CN |
| Decision | Substantially Equivalent, Mar 23, 2022 |
| Received | Aug 18, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212626
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.