FDA 510(k) Applications Submitted by IRVINE BIOMEDICAL, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K042775 |
10/06/2004 |
INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER |
IRVINE BIOMEDICAL, INC. |
| K060757 |
03/21/2006 |
INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER |
IRVINE BIOMEDICAL, INC. |
| K053582 |
12/23/2005 |
INQUIRY AFOCUS II DIAGNOSTIC CATHETER |
IRVINE BIOMEDICAL, INC. |
| K010471 |
02/20/2001 |
AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569 |
IRVINE BIOMEDICAL, INC. |
| K082061 |
07/21/2008 |
INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER |
IRVINE BIOMEDICAL, INC. |
| K961924 |
05/17/1996 |
IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM |
IRVINE BIOMEDICAL, INC. |
| K990958 |
03/22/1999 |
ORTHOGONAL EP CATHETERS |
IRVINE BIOMEDICAL, INC. |
| K991025 |
03/29/1999 |
LUMA-CATH FIXED CURVE EP CATHETERS |
IRVINE BIOMEDICAL, INC. |
| K991878 |
06/02/1999 |
LUMA-CATH STEERABLE EP CATHETERS |
IRVINE BIOMEDICAL, INC. |
| K982232 |
06/25/1998 |
MODIFICATION OF THE IBI-1100 STEERABLE ELECTROPHYSIOLOGY CATHETER SYSTEM |
IRVINE BIOMEDICAL, INC. |
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