FDA 510(k) Applications Submitted by INTRALUMINAL THERAPEUTICS, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K040037 |
01/09/2004 |
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM |
INTRALUMINAL THERAPEUTICS, INC. |
| K010531 |
02/23/2001 |
ILT DEFLECTING CATHETER, MODEL C114ND1 |
INTRALUMINAL THERAPEUTICS, INC. |
| K040481 |
02/25/2004 |
SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1 |
INTRALUMINAL THERAPEUTICS, INC. |
| K030984 |
03/28/2003 |
SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT CATHETER 0.14, SAFE CROSS ANGLED SUPPORT CATHETER, SAFE CROT |
INTRALUMINAL THERAPEUTICS, INC. |
| K050915 |
04/12/2005 |
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY] |
INTRALUMINAL THERAPEUTICS, INC. |
| K050916 |
04/12/2005 |
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL] |
INTRALUMINAL THERAPEUTICS, INC. |
| K021243 |
04/19/2002 |
ILT TORQUER, MODEL 114TR1 |
INTRALUMINAL THERAPEUTICS, INC. |
| K021323 |
04/26/2002 |
MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM |
INTRALUMINAL THERAPEUTICS, INC. |
| K031417 |
05/05/2003 |
ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1 |
INTRALUMINAL THERAPEUTICS, INC. |
| K021638 |
05/20/2002 |
ILT ADVANCING MECHANISM, MODEL A115AMI |
INTRALUMINAL THERAPEUTICS, INC. |
| K031692 |
06/02/2003 |
SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 |
INTRALUMINAL THERAPEUTICS, INC. |
| K031842 |
06/16/2003 |
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM |
INTRALUMINAL THERAPEUTICS, INC. |
| K001992 |
06/29/2000 |
ILT 0.014 CATHETER, MODEL C114NL2 |
INTRALUMINAL THERAPEUTICS, INC. |
| K032031 |
07/01/2003 |
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM |
INTRALUMINAL THERAPEUTICS, INC. |
| K012169 |
07/12/2001 |
ILT SUPPORT CATHETER .014, MODEL C114LW1; ILT SUPPORT CATHETER ADVANCING MECHANISM, MODEL A11AM1 |
INTRALUMINAL THERAPEUTICS, INC. |
| K041973 |
07/22/2004 |
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM |
INTRALUMINAL THERAPEUTICS, INC. |
| K032784 |
09/08/2003 |
ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 |
INTRALUMINAL THERAPEUTICS, INC. |
| K033708 |
11/26/2003 |
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM |
INTRALUMINAL THERAPEUTICS, INC. |
| K033929 |
12/18/2003 |
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM |
INTRALUMINAL THERAPEUTICS, INC. |
| K011986 |
06/26/2001 |
SAFE-STEER GUIDE WIRE SYSTEM |
INTRALUMINAL THERAPEUTICS, INC. |
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