Irvine Biomedical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Irvine Biomedical, Inc. - FDA 510(k) Cleared Devices
11
Total
11
Cleared
0
Denied
Irvine Biomedical, Inc. has 11 FDA 510(k) cleared cardiovascular devices. Based in Irvine, US.
Historical record: 11 cleared submissions from 1995 to 2008.
Browse the complete list of FDA 510(k) cleared cardiovascular devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Irvine Biomedical, Inc.
11 devices
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