K223824 is an FDA 510(k) clearance for the 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), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure Sensor. This device is classified as a Catheter, Steerable (Class II - Special Controls, product code DRA).
Submitted by Boston Scientific Corporation (St Paul, US). The FDA issued a Cleared decision on March 22, 2023, 91 days after receiving the submission on December 21, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1280.
| 510(k) Number | K223824 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2022 |
| Decision Date | March 22, 2023 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRA — Catheter, Steerable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1280 |