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Sign in to claim this brandIrvine Biomedical, Inc.(Ibi)
US
Last updated May 23, 2026
What Irvine Biomedical, Inc.(Ibi) makes
Irvine Biomedical, Inc. (Ibi) manufactures intracardiac echocardiography ultrasound imaging catheters, including the IBI Inquiry ClearIce model, and ablation catheters such as the Safire TX Ablation Catheter and Therapy Dual-8 Ablation Catheter, along with associated catheter extension cables and therapy cables.
The company's devices are classified as Class II and Class III medical devices and are listed in the FDA's 510(k) and PMA registries; Irvine Biomedical, Inc. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Irvine Biomedical, Inc. (Ibi) manufacture?
Irvine Biomedical, Inc. (Ibi) manufactures intracardiac echocardiography ultrasound imaging catheters, such as the IBI Inquiry ClearIce model, and ablation catheters including the Safire TX Ablation Catheter and Therapy Dual-8 Ablation Catheter, along with associated catheter extension cables and therapy cables, as specified in the provided device data.
Where is Irvine Biomedical, Inc. (Ibi) based?
Irvine Biomedical, Inc. (Ibi) is based in the United States, as explicitly stated in the country field of the device data.
In which regulatory registries are Irvine Biomedical, Inc.'s devices listed?
Irvine Biomedical, Inc.'s devices are listed in the FDA's 510(k) and PMA registries, as indicated in the LISTED IN field of the device data.
How are Irvine Biomedical, Inc.'s devices classified?
Irvine Biomedical, Inc.'s devices are classified as Class II and Class III medical devices, as stated in the DEVICE CLASSES field of the device data.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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- PRRC Contact
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- EUDAMED SRN
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Catalogue (216)
Page 3 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Inquiry™ | IBI-81521 | FDA UDI | Class II | Active |
| Sjm™ | IBI-85641 | FDA UDI | Class III | Active |
| Sjm™ | 1914-SA | FDA UDI | Class II | Active |
| Inquiry™ | IBI-81126 | FDA UDI | Class II | Active |
| Therapy™ | IBI-83372 | FDA UDI | Class III | Active |
| Inquiry™ | IBI-80250 | FDA UDI | Class II | Active |
| Safire™ Blu™ SP | A402870 | FDA UDI | Class III | Unknown |
| Inquiry™ | IBI-81504 | FDA UDI | Class II | Active |
| Inquiry™ | IBI-81918 | FDA UDI | Class II | Active |
| Safire™ TX | 402579 | FDA UDI | Class III | Active |
| Safire™ Blu™ Duo SP | A088106 | FDA UDI | Class III | Unknown |
| Therapy™ | IBI-83725 | FDA UDI | Class III | Unknown |
| Inquiry™ | IBI-81542 | FDA UDI | Class II | Active |
| Safire™ Blu™ SP | A402872 | FDA UDI | Class III | Unknown |
| Inquiry™ | D087024 | FDA UDI | Class II | Active |
| Inquiry™ | IBI-80064 | FDA UDI | Class II | Active |
| Inquiry™ | IBI-81599 | FDA UDI | Class II | Active |
| Inquiry™ | IBI-80003 | FDA UDI | Class II | Active |
| Therapy™ | IBI-83329 | FDA UDI | Class III | Active |
| Inquiry™ | IBI-81144 | FDA UDI | Class II | Active |
| Inquiry™ | IBI-81417 | FDA UDI | Class II | Active |
| Inquiry™ | IBI-81209 | FDA UDI | Class II | Active |
| Therapy™ | IBI-84308 | FDA UDI | Class III | Active |
| Inquiry™ AFocus II™ | IBI-87008 | FDA UDI | Class II | Active |
| Therapy™ | IBI-83371 | FDA UDI | Class III | Active |
| Safire™ Blu™ Duo SP | A088108 | FDA UDI | Class III | Unknown |
| Therapy™ | IBI-84311 | FDA UDI | Class III | Active |
| Inquiry™ | IBI-80465 | FDA UDI | Class II | Active |
| Safire™ TX | 402839 | FDA UDI | Class III | Active |
| Inquiry™ | IBI-81120 | FDA UDI | Class II | Active |
| Inquiry™ | IBI-87007 | FDA UDI | Class II | Active |
| Therapy™ | Cool Path SP | FDA UDI | Class III | Unknown |
| Inquiry™ | IBI-80804 | FDA UDI | Class II | Active |
| Therapy™ | IBI-84309 | FDA UDI | Class III | Active |
| Therapy™ | Cool Path™ SP | FDA UDI | Class III | Unknown |
| Sjm™ | IBI-85809 | FDA UDI | Class III | Active |
| Inquiry™ | IBI-81121 | FDA UDI | Class II | Active |
| Inquiry™ | IBI-81474 | FDA UDI | Class II | Active |
| Therapy™ | IBI-83445 | FDA UDI | Class III | Active |
| Inquiry™ | IBI-81938 | FDA UDI | Class II | Active |
| Inquiry™ | IBI-81920 | FDA UDI | Class II | Active |
| Inquiry™ | IBI-81472 | FDA UDI | Class II | Active |
| Therapy™ | IBI-83721 | FDA UDI | Class III | Unknown |
| Inquiry™ | IBI-81224 | FDA UDI | Class II | Active |
| Inquiry™ | IBI-81730 | FDA UDI | Class II | Active |
| Inquiry™ | IBI-81590 | FDA UDI | Class II | Active |
| Inquiry™ | IBI-81508 | FDA UDI | Class II | Active |
| Inquiry™ | IBI-80567 | FDA UDI | Class II | Active |
| Inquiry™ | IBI-81226 | FDA UDI | Class II | Active |
| Inquiry™ | IBI-81526 | FDA UDI | Class II | Active |
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