Medical Device Manufacturer · US , Irvine , CA

Irvine Biomedical, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 1995

Recent clearances: MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM

11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Irvine Biomedical, Inc. Cardiovascular ✕

11 devices

1-11 of 11

Cleared Aug 19, 2008

INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER

Cardiovascular · 29d

Cleared Apr 19, 2006

INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER

Cardiovascular · 29d

Cleared Mar 21, 2006

INQUIRY AFOCUS II DIAGNOSTIC CATHETER

Cardiovascular · 88d

Cleared Nov 04, 2004

INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE...

Cardiovascular · 29d

Cleared Jun 06, 2001

AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569

Cardiovascular · 106d

Cleared Dec 10, 1999

LUMA-CATH STEERABLE EP CATHETERS

Cardiovascular · 191d

Cleared Oct 15, 1999

LUMA-CATH FIXED CURVE EP CATHETERS

Cardiovascular · 200d

Cleared Jun 03, 1999

ORTHOGONAL EP CATHETERS

Cardiovascular · 73d

Cleared Jul 25, 1998

MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM

Cardiovascular · 30d

Cleared Apr 11, 1997

IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM

Cardiovascular · 329d

Cleared Jul 18, 1995

IBI-1000(TM) ELECTROPHYSIOLOGY CATHTER

Cardiovascular · 201d