This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.
Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.
Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.
| Market | Identifier | Name | Class / date |
|---|---|---|---|
| US | K992912 | CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH | 2000-03-08 |
| US | K990795 | MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER; CARDIAC PATHWAYS EGM ADAPTER CABLES | 1999-06-08 |
| US | K982540 | MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER MODELS, 7005, 7006, 7007, MERCATOR ATRIAL HIGH DENSITY ARRAY DEPLOYMENT KIT, | 1999-01-27 |
| CA | 13461 | NEXUS LINEAR ABLATION CATHETER, DEPLOYMENT KITS (GUIDING SHEATHS), AND EGM CONNECTING CABLES | Class IV |
| CA | 13522 | RADII-T 7F STEERABLE ELECTROPHYSIOLOGY CATHETER | Class IV |
| CA | 13523 | ENSEMBLE 2F ELECTROPHYSIOLOGY CATHETER AND ACCESSORIES | Class IV |