Cryterion Medical Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3027305778 | 3027305778 | Cryterion Medical Inc. | 1 | N | 2026-01-01 | 5920 Boulevard Henri-Bourassa Ouest Saint Laurent Quebec CA H4R 1V9 |
| 3013634963 | 3013634963 | CRYTERION MEDICAL, INC. | 1 | N | 2020-04-25 | 1949 PALOMAR OAKS WAY STE 100 Carlsbad CA US 92011 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 317161 | 1382237580 | P220032 | POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories | OAE | 2023-08-08 |
| 317161 | 1247745980 | K223824 | 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 | DRA | 2023-03-22 |
| 222768 | 1222567756 | ||||
| 222768 | 1427521473 | ||||
| 222768 | 1432857608 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| DRA | 1 | 2023-03-22 |