Intra Luminal Therapeutics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL], SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY], MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
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