510(k) K223824 · DRA Catheter, Steerable
POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMART
| Applicant | Boston Scientific Corporation, St Paul MN, US |
| Decision | Substantially Equivalent, Mar 22, 2023 |
| Received | Dec 21, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223824
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 26, 2024 | Boston Scientific Corporation Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050 Open, Classified |
DRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.