Question 1

What types of medical devices does Irvine Biomedical, Inc. (Ibi) manufacture?

Accepted Answer

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.

Question 2

Where is Irvine Biomedical, Inc. (Ibi) based?

Accepted Answer

Irvine Biomedical, Inc. (Ibi) is based in the United States, as explicitly stated in the country field of the device data.

Question 3

In which regulatory registries are Irvine Biomedical, Inc.'s devices listed?

Accepted Answer

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.

Question 4

How are Irvine Biomedical, Inc.'s devices classified?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Safire™ Blu™ SP	A402871	FDA UDI	Class III	Unknown
Ibi-1000(tm) Electrophysiology Cathter	K946333	FDA 510(k)	Class II	Active
Inquiry H-Curve Tv Steerable Diagnostic Catheter	K082061	FDA 510(k)	Class II	Active
Orthogonal Ep Catheters	K990958	FDA 510(k)	Class II	Active
Luma-Cath Fixed Curve Ep Catheters	K991025	FDA 510(k)	Class II	Active
Afocus Electropysiology Catheter System, Models 81550, 81567, 81568, 81569	K010471	FDA 510(k)	Class II	Active
Inquiry Afocus Ii Diagnostic Catheter	K053582	FDA 510(k)	Class II	Active
Luma-Cath Steerable Ep Catheters	K991878	FDA 510(k)	Class II	Active
Inquiry Optima Plus Steerable Electrophysiology Catheter	K060757	FDA 510(k)	Class II	Active
Ibi-1100 Steerable Electrophysiology Catheter System	K961924	FDA 510(k)	Class II	Active
Inquiry Afocus, Inquiry Afocus Ii And Inquiry Optima Steerable Electrophysiology Catheter	K042775	FDA 510(k)	Class II	Active
Modification Of The Ibi-1100 Steerable Electrophysiology Catheter System	K982232	FDA 510(k)	Class II	Active
Ibi Inquiry Clearice Intracardiac Echocardiography Ultrasound Imaging Catheter	K070011	FDA 510(k)	Class II	Active
Therapy Cardiac Ablation System	P040014	FDA PMA	Class III	Active
Therapy Cool Path Ablation Catheter & Ibi 1500t9	P060019	FDA PMA	Class III	Active
Safire™ TX Ablation Catheter, Safire™ TX, Catheter Extension Cable, Therapy™ Dual-8™ Ablation Catheter, Cables 16- 17- 1	P040042	FDA PMA	Class III	Active

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