Panels › Cardiovascular › Product code QEW · Class 2
Peripheral Mechanical Thrombectomy With Aspiration
Regulation 870.5150
12510(k)s in 12 months (146 all time)
0recalls in 12 months (10 all time)
10recalls that name a 510(k)
Top companies in QEW
| Company | 510(k)s | Recalls |
|---|---|---|
| Inari Medical | 49 | 0 |
| Penumbra, Inc. | 27 | 0 |
| TELEFLEX MEDICAL INC | 0 | 7 |
| Devoro Medical, Inc. | 5 | 0 |
| Inquis Medical | 5 | 0 |
| Surmodics,Inc. | 5 | 0 |
| Vascular Medcure, Inc. | 5 | 0 |
| Argon Medical Devices, Inc. | 4 | 0 |
| Contego Medical, Inc. | 4 | 0 |
| Endovascular Engineering | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2025 | Inari Medical - Oak Canyon Artix MT Thrombectomy Device, REF: 32-102 Open, Classified |
QEW | K241894 |
| Aug 21, 2024 | Inari Medical - Oak Canyon ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ClotTriever XL Catheter ClotTriever Thrombectomy System, Reference: IU-01011 Open, Classified |
QEW | K223210 |
| Jun 26, 2024 | Mermaid Medical A/S The D*Clot HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spir Open, Classified |
QEW | K021641 |
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), REF PT-65509 (finished good kit)
The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunction with the Arrow Rotato Terminated |
QEW | K011056 |
| Feb 15, 2022 | TELEFLEX MEDICAL INC 5 Fr. X 65 cm Arrow-Trerotola PTD Kit, Percutaneous Thrombolytic Device, REF PT-65509-HFC containing components: PT-03000, PT-65509-S (PT-65509-S2 alternative), PT-01000-D (PT-01000-D2 alternative)
Terminated |
QEW | K011056 |
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device), PT-45509 containing components: PT-45509-S6, PT-45509-T
The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjunctio Terminated |
QEW | K011056 |
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-WC containing components: PT-65709-C, PT-03009, PT-65709-HS
The Arrow-Trerotola Percutaneous Thrombolytic Devic Terminated |
QEW | K011056 |
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-W containing component: PT-65709-C
The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter, in conjun Terminated |
QEW | K011056 |
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-65709-HFWC containing components: PT-65709-C, PT-03009, PT-65709-HFS
The Arrow-Trerotola Percutaneous Thrombolytic Dev Terminated |
QEW | K011056 |
| Feb 15, 2022 | TELEFLEX MEDICAL INC Arrow-Trerotola Over-The-Wire PTD Kit, Percutaneous Thrombolytic Device, REF PT-12709-WC, containing components: PT-12709-CA, PT-12709-C,
The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Terminated |
QEW | K011056 |
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