Data / Medical devices / Canada / Cryterion Medical Inc.
Cryterion Medical Inc.: FDA-registered device maker in Saint Laurent Quebec, Canada, 1 510(k) clearance and 1 PMA approval
Cryterion Medical Inc. is registered with the FDA (registration 3027305778) in Saint Laurent Quebec, Canada. It lists 3 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated August 8, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027305778
- Address
- 5920 Boulevard Henri-Bourassa Ouest, Saint Laurent Quebec, Canada, H4R 1V9
- Owner or operator
- Boston Scientific Corporation (9912058)
- Roles
- Specification developer
- First device listed
- May 8, 2023
- Registered through
- 2026
- Brand names listed
- POLARx Cryoablation Balloon Catheter, POLARx FIT Cryoablation Balloon Catheter, SMARTFREEZE Catheter Extension Cable, SMARTFREEZE Cryo-Cable, SMARTFREEZE Cryo-Console, SMARTFREEZE Cryo-Console Foot Switch, SMARTFREEZE Diaphragm Movement Sensor, SMARTFREEZE Inter-Connection Box and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Electrode Recording, Or Probe, Electrode Recording | DRF | 2 | Specification developer | accessdata.fda.gov |
| Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation | OAE | 3 | Specification developer | accessdata.fda.gov |
| Catheter, Steerable | DRA | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 22, 2023 | 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 | Substantially Equivalent | Boston Scientific Corporation | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 8, 2023 | P220032 | POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories | OAE | 12 | May 29, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- All makers of Catheter, Electrode Recording, Or Probe, Electrode Recording
- All makers of Catheter, Steerable
Updated May 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.