Company · US
Thrombolex, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2023. Name variants (Inc, Corp, punctuation) are merged.
6510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QEY | Mechanical Thrombolysis Catheter | 6 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 3, 2023 | K231653 | BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter Thrombolex, Inc. | QEY |
| Apr 20, 2023 | K222095 | BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 Thrombolex, Inc. | QEY |
| Jun 10, 2021 | K211061 | BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Thrombolex, Inc. | QEY |
| Dec 17, 2019 | K193071 | Bashir Plus Endovascular Catheter Thrombolex, Inc. | QEY |
| Oct 18, 2019 | K192598 | Bashir S-B Endovascular Catheter, Ref. No. 7101 Thrombolex, Inc. | QEY |
| Feb 25, 2019 | K183290 | Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 Thrombolex, Inc. | QEY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||