Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intra Luminal Therapeutics, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
57 daysmedian FDA review time
190 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050916 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [ | Intra Luminal Therapeutics, Inc. | 2005-06-08 | 57 | 0 |
| K050915 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [ | Intra Luminal Therapeutics, Inc. | 2005-06-07 | 56 | 0 |
| K041973 | MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION C | Intra Luminal Therapeutics, Inc. | 2004-08-16 | 25 | 0 |
| K040481 | SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1 | Intra Luminal Therapeutics, Inc. | 2004-03-18 | 22 | 0 |
| K040037 | MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION C | Intra Luminal Therapeutics, Inc. | 2004-03-03 | 54 | 0 |
| K033929 | MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION C | Intra Luminal Therapeutics, Inc. | 2004-01-12 | 25 | 0 |
| K032031 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | Intra Luminal Therapeutics, Inc. | 2004-01-07 | 190 | 0 |
| K033708 | MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION C | Intra Luminal Therapeutics, Inc. | 2003-12-11 | 15 | 0 |
| K031842 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | Intra Luminal Therapeutics, Inc. | 2003-11-21 | 158 | 0 |
| K032784 | ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 | Intra Luminal Therapeutics, Inc. | 2003-11-18 | 71 | 0 |
| K031692 | SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 | Intra Luminal Therapeutics, Inc. | 2003-08-22 | 81 | 0 |
| K031417 | ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1 | Intra Luminal Therapeutics, Inc. | 2003-07-11 | 67 | 0 |
| K030984 | SAFE CROSS ANGLED SUPPORT 0.14, SAFE CROSS STRAIGHT SUPPORT | Intra Luminal Therapeutics, Inc. | 2003-04-24 | 27 | 0 |
| K021638 | ILT ADVANCING MECHANISM, MODEL A115AMI | Intra Luminal Therapeutics, Inc. | 2002-07-26 | 67 | 0 |
| K021243 | ILT TORQUER, MODEL 114TR1 | Intra Luminal Therapeutics, Inc. | 2002-07-11 | 83 | 0 |
| K021323 | MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM | Intra Luminal Therapeutics, Inc. | 2002-05-22 | 26 | 0 |
| K011986 | SAFE-STEER GUIDE WIRE SYSTEM | Intra Luminal Therapeutics, Inc. | 2002-04-03 | 281 | 0 |
| K012169 | ILT SUPPORT CATHETER .014, MODEL C114LW1; ILT SUPPORT CATHET | Intra Luminal Therapeutics, Inc. | 2001-08-30 | 49 | 0 |
| K010531 | ILT DEFLECTING CATHETER, MODEL C114ND1 | Intra Luminal Therapeutics, Inc. | 2001-04-18 | 54 | 0 |
| K001992 | ILT 0.014 CATHETER, MODEL C114NL2 | Intra Luminal Therapeutics, Inc. | 2000-09-25 | 88 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda