FDA Registration
Active
🇨🇦 Canada
Cryterion Medical Inc.
Reg #: 3027305778
·
FEI: 3027305778
·
Expires 2026
Products
3
Proprietary Names
9
Establishment Types
1
Classifications
3
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Registration Details
- Registration Name
- Cryterion Medical Inc.
- Registration Number
- 3027305778
- FEI Number
- 3027305778
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5920 Boulevard Henri-Bourassa Ouest
- City
- Saint Laurent Quebec
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K223824
- PMA Number
- P220032
Owner / Operator
- Firm Name
- Boston Scientific Corporation
- Operator Number
- 9912058
- Address
- 300 Boston Scientific Way
- City
- Marlborough
- State
- MA
- Postal Code
- 01752
- Country
- US
- Correspondent
- Adrienne Bishop
US Agent
- Business Name
- BOSTON SCIENTIFIC CORPORATION
- Contact Name
- Aaron Dunbar
- Address
- 300 Boston Scientific Way
- City
- Marlborough
- State
- MA
- ZIP
- 01752
- Country
- US
- [email protected]
- Phone
- 651 3961414
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | Class 3 | Unknown | No | 2023-08-10 |
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | Class 2 | Cardiovascular | No | 2023-05-08 |
| Catheter, Steerable | DRA | Class 2 | Cardiovascular | No | 2023-05-08 |
Proprietary Names
SMARTFREEZE Cryo-Cable
SMARTFREEZE Catheter Extension Cable
SMARTFREEZE Cryo-Console
SMARTFREEZE Inter-Connection Box
SMARTFREEZE Cryo-Console Foot Switch
POLARx Cryoablation Balloon Catheter
SMARTFREEZE Remote Control
POLARx FIT Cryoablation Balloon Catheter
SMARTFREEZE Diaphragm Movement Sensor
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility