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Sign in to claim this brandChad Therapeutics, Inc.
US
Last updated May 23, 2026
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Catalogue (36)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| C2 CryoBalloon Ablation System | K163684 | FDA 510(k) | Class II | Active |
| C2 CryoBalloon Focal Controller | FG-1012 | FDA UDI | Class II | Active |
| C2 CryoBalloon Full 8 Catheter | FG-1032 | FDA UDI | Class II | Active |
| Controller, Full/Swipe | FG-1006 | FDA UDI | Class II | Active |
| C2 CryoBalloon Cartridge, Large | FG-1013 | FDA UDI | Class II | Active |
| Sidecar External Working Channel | FG-1011 | FDA UDI | Class II | Active |
| C2 CryoBalloon Cartridge, Regular | FG-1010 | FDA UDI | Class II | Active |
| C2 CryoBalloon | FG-1026 | FDA UDI | Class II | Active |
| C2 CryoBalloon Focal Pear Catheter | FG-1033 | FDA UDI | Class II | Active |
| C2 CryoBalloon Swipe Catheter, Standard | FG-1015 | FDA UDI | Class II | Active |
| BOA Endoscopic Valve | FG-1016 | FDA UDI | Class II | Active |
| C2 CryoBalloon Focal Catheter, Standard | FG-1009 | FDA UDI | Class II | Active |
| C2 CryoBalloon | FG-1017 | FDA UDI | Class II | Active |
| Catheter, Full, Standard | FG-1008 | FDA UDI | Class II | Active |
| Oxycoil | K854239 | FDA 510(k) | Class I | Active |
| Total O2 | K013472 | FDA 510(k) | Class II | Active |
| Chad Adjustable Cannula | K842968 | FDA 510(k) | Class I | Active |
| Oxymizer | K830009 | FDA 510(k) | Class II | Active |
| Flochannel | K081176 | FDA 510(k) | Class II | Active |
| Chad Therapeutics Sage | K033364 | FDA 510(k) | Class II | Active |
| Oxymizer-Pendant | K834588 | FDA 510(k) | Class II | Active |
| Coldplay CryoBalloon® Ablation System | K153541 | FDA 510(k) | Class II | Active |
| C2 CryoBalloon Focal Pear Catheter | K160994 | FDA 510(k) | Class II | Active |
| Chad Therapeutics Oxymatic Model 401 And Oxymatic Model 411 | K010389 | FDA 510(k) | Class II | Active |
| Chad Therapeutics Bonsai Model 800 | K070740 | FDA 510(k) | Class II | Active |
| Chad Therapeutics Oxypenumatic Cypress Model 511 | K020475 | FDA 510(k) | Class II | Active |
| Modification To Chad Therapeutics Oxymatic Model 401 | K003455 | FDA 510(k) | Class II | Active |
| Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System | K152329 | FDA 510(k) | Class II | Active |
| Oxymatictm Electronic Oxgyen Conserver | K852650 | FDA 510(k) | Class II | Active |
| Chad Therapeutics Oxymatic Model 401 | K000890 | FDA 510(k) | Class II | Active |
| Oxymizer Flow Restrictor | K841901 | FDA 510(k) | Class I | Active |
| Chad Therapeutics Lotus, Models Om-700 And Om-700s | K042142 | FDA 510(k) | Class II | Active |
| Boa Endoscopic Valve | K152140 | FDA 510(k) | Class II | Active |
| Chad Total O2 Delivery System | K971889 | FDA 510(k) | Class II | Active |
| Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System | K151054 | FDA 510(k) | Class II | Active |
| Oxymatic-24 | K884562 | FDA 510(k) | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 25, 2005 | Z-1068-05 | — | terminated | "Shot size" below manufacturing specifications. Risk of less than the specified quantity of oxygen delivered per pulse. |