Intra Luminal Therapeutics, Inc. - FDA 510(k) Cleared Devices
20
Total
20
Cleared
0
Denied
FDA 510(k) Regulatory Record - Intra Luminal Therapeutics, Inc. Cardiovascular ✕
20 devices
Cleared
Jun 08, 2005
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]
Cardiovascular
57d
Cleared
Jun 07, 2005
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]
Cardiovascular
56d
Cleared
Aug 16, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
Cardiovascular
25d
Cleared
Mar 18, 2004
SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1
Cardiovascular
22d
Cleared
Mar 03, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
Cardiovascular
54d
Cleared
Jan 12, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
Cardiovascular
25d
Cleared
Jan 07, 2004
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
Cardiovascular
190d
Cleared
Dec 11, 2003
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
Cardiovascular
15d
Cleared
Nov 21, 2003
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
Cardiovascular
158d
Cleared
Nov 18, 2003
ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
Cardiovascular
71d
Cleared
Aug 22, 2003
SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1
Cardiovascular
81d
Cleared
Jul 11, 2003
ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1
Cardiovascular
67d
Cleared
Apr 24, 2003
SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14,...
Cardiovascular
27d
Cleared
Jul 26, 2002
ILT ADVANCING MECHANISM, MODEL A115AMI
Cardiovascular
67d
Cleared
Jul 11, 2002
ILT TORQUER, MODEL 114TR1
Cardiovascular
83d
Cleared
May 22, 2002
MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM
Cardiovascular
26d
Cleared
Apr 03, 2002
SAFE-STEER GUIDE WIRE SYSTEM
Cardiovascular
281d
Cleared
Aug 30, 2001
ILT SUPPORT CATHETER .014, MODEL C114LW1
Cardiovascular
49d
Cleared
Apr 18, 2001
ILT DEFLECTING CATHETER, MODEL C114ND1
Cardiovascular
54d
Cleared
Sep 25, 2000
ILT 0.014 CATHETER, MODEL C114NL2
Cardiovascular
88d