Data / Medical devices / United States / Thrombolex, Inc.
Thrombolex, Inc.: FDA-registered device maker in New Britain, PA, United States, 3 510(k) clearances
Thrombolex, Inc. is registered with the FDA (registration 3015489145) in New Britain, PA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 3, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015489145
- Address
- 75 Britain Dr., New Britain, PA, United States, 18901
- Owner or operator
- Thrombolex, Inc. (10059988)
- Roles
- Specification developer
- First device listed
- November 30, 2022
- Registered through
- 2026
- Brand names listed
- BASHIR 35 Endovascular Catheter, BASHIR Endovascular Catheter, BASHIR Plus Endovascular Catheter, THROMBOLEX 7Fr +10 Endovascular Device, THROMBOLEX 7Fr +20 Endovascular Device, THROMBOLEX 7Fr +30 Endovascular Device, THROMBOLEX 7Fr +40 Endovascular Device, THROMBOLEX 7Fr Endovascular Device and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Continuous Flush | KRA | 2 | Specification developer | accessdata.fda.gov |
| Mechanical Thrombolysis Catheter | QEY | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 3, 2023 | K231653 | BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter | QEY | Substantially Equivalent | Thrombolex, Inc. | accessdata.fda.gov |
| April 20, 2023 | K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 | QEY | Substantially Equivalent | Thrombolex, Inc. | accessdata.fda.gov |
| June 10, 2021 | 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 | Substantially Equivalent | Thrombolex, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 3, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.