Intra Luminal Therapeutics, Inc.: FDA filings under this applicant name
FDA lists 20 510(k) clearances under the applicant name “Intra Luminal Therapeutics, Inc.” (first 2000, latest 2005), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 56 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 10 | 10 |
| DQY | Catheter, Percutaneous | 8 | 8 |
| PDU | Catheter For Crossing Total Occlusions | 2 | 2 |
Review panels
- Cardiovascular (20)
Most recent Intra Luminal Therapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K050916 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL] | PDU | 2005-06-08 | 57 |
| K050915 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY] | DQX | 2005-06-07 | 56 |
| K041973 | MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | DQX | 2004-08-16 | 25 |
| K040481 | SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1 | DQY | 2004-03-18 | 22 |
| K040037 | MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | DQX | 2004-03-03 | 54 |
| K033929 | MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | DQX | 2004-01-12 | 25 |
| K032031 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | DQX | 2004-01-07 | 190 |
| K033708 | MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | DQX | 2003-12-11 | 15 |
| K031842 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | PDU | 2003-11-21 | 158 |
| K032784 | ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 | DQY | 2003-11-18 | 71 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Intra Luminal Therapeutics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Intra Lase Corp. (9 510(k)s)
- Intra Special Catheters GmbH (1 510(k)s)
- Intra Vantage, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intra Luminal Therapeutics, Inc.?
FDA lists 20 510(k) clearances under the applicant name “Intra Luminal Therapeutics, Inc.” (first 2000, latest 2005), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Intra Luminal Therapeutics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intra Luminal Therapeutics, Inc. is 56 days.
Which FDA product codes appear under Intra Luminal Therapeutics, Inc.?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 10); DQY (Catheter, Percutaneous, 8); PDU (Catheter For Crossing Total Occlusions, 2).
Next steps
- See all 20 Intra Luminal Therapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Intra Luminal Therapeutics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.