Thrombolex, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Thrombolex, Inc.” (first 2019, latest 2023), across 1 product code in 1 review panel. Median 510(k) review time under this name: 52 days. Since 2017 the median was 52 days, against 91 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2019 | 3 | 43 |
| 2020 | 0 | — |
| 2021 | 1 | 62 |
| 2022 | 0 | — |
| 2023 | 2 | 152 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Thrombolex, Inc. took a median 52 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QEY | Mechanical Thrombolysis Catheter | 6 | 6 |
Review panels
- Cardiovascular (6)
Most recent Thrombolex, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231653 | BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter | QEY | 2023-07-03 | 27 |
| K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 | QEY | 2023-04-20 | 276 |
| K211061 | BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240) | QEY | 2021-06-10 | 62 |
| K193071 | Bashir Plus Endovascular Catheter | QEY | 2019-12-17 | 43 |
| K192598 | Bashir S-B Endovascular Catheter, Ref. No. 7101 | QEY | 2019-10-18 | 28 |
| K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 | QEY | 2019-02-25 | 91 |
Recalls
openFDA lists no recalls under a recalling firm named Thrombolex, 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.
Device clinical trials
An industry sponsor named Thrombolex, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT04248868: tPA by Endovascular Administration for the Treatment of Submassive PE Using CDT for the Reduction of Thrombus Burden (Completed, started 2020-06-23)
- NCT03927508: First - In - Man Study to Assess the Safety and Feasibility of The Bashir™ Endovascular Catheter for the Treatment of Acute Pulmonary Embolism (Completed, started 2019-03-14)
Frequently asked questions
How many FDA 510(k) clearances are listed under Thrombolex, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Thrombolex, Inc.” (first 2019, latest 2023), across 1 product code 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 Thrombolex, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thrombolex, Inc. is 52 days. Since 2017: 52 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Thrombolex, Inc.?
The most frequent FDA product codes under this applicant name are QEY (Mechanical Thrombolysis Catheter, 6).
Next steps
- See all 6 Thrombolex, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QEY, Thrombolex, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.