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Irvine Biomedical, Inc.

FDA 510(k) & PMA Approved Devices — 11 products

Total Devices11

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K082061	INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER	DRF	2008-08-19	View
510(k)	K060757	INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER	DRF	2006-04-19	View
510(k)	K053582	INQUIRY AFOCUS II DIAGNOSTIC CATHETER	DRF	2006-03-21	View
510(k)	K042775	INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER	DRF	2004-11-04	View
510(k)	K010471	AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569	DRF	2001-06-06	View
510(k)	K991878	LUMA-CATH STEERABLE EP CATHETERS	DRF	1999-12-10	View
510(k)	K991025	LUMA-CATH FIXED CURVE EP CATHETERS	DRF	1999-10-15	View
510(k)	K990958	ORTHOGONAL EP CATHETERS	DRF	1999-06-03	View
510(k)	K982232	MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM	DRF	1998-07-25	View
510(k)	K961924	IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM	DRF	1997-04-11	View
510(k)	K946333	IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER	DRF	1995-07-18	View

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