Device Listing 1247745980
Listing Summary
- Listing key
- 1247745980
- Premarket submission
- K223824
- Device
- 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
- Applicant
- Boston Scientific Corporation
- Product code
- DRA
- Decision date
- 2023-03-22
Related Registrations
| Registration key | Registration | FEI | Company | Status | Initial importer | Expiration | Address |
|---|---|---|---|---|---|---|---|
| 122195 | 2124215 | 2124215 | Boston Scientific Corporation | 1 | Y | 2026-01-01 | 4100 Hamline Ave N Saint Paul MN US 55112 |
| 26758 | 9681260 | 3002806565 | Boston Scientific Limited | 1 | N | 2026-01-01 | BALLYBRIT BUSINESS PARK GALWAY IE -- |
| 175629 | 1000121056 | 1000121056 | Boston Scientific Corporation | 1 | N | 2026-01-01 | 8 Industrial Dr Coventry RI US 02816 |
| 26737 | 3004859241 | 3004859241 | Aaron Dunbar | 1 | N | 2026-01-01 | 300 Boston Scientific Way Marlborough MA US 01752 |
| 317161 | 3027305778 | 3027305778 | Cryterion Medical Inc. | 1 | N | 2026-01-01 | 5920 Boulevard Henri-Bourassa Ouest Saint Laurent Quebec CA H4R 1V9 |