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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 23, 2023 | K223419 | Triever16 Curve Inari Medical | QEW |
| Mar 17, 2023 | K223613 | InThrill Thrombectomy System Inari Medical, Inc. | QEW |
| Mar 14, 2023 | K223609 | RevCore Thrombectomy Catheter. Inari Medical, Inc. | QEW |
| Mar 7, 2023 | K230331 | Protrieve Sheath Inari Medical, Inc. | QEW |
| Mar 2, 2023 | K223436 | Artix AX Inari Medical | QEW |
| Feb 23, 2023 | K223216 | Symphony Thrombectomy System Truvic Medical, Inc. | QEW |
| Feb 17, 2023 | K223897 | Excipio LV Thrombectomy Device Contego Medical, Inc. | QEW |
| Feb 15, 2023 | K223891 | Cobra Catheter System Endovascular Engineering | QEW |
| Feb 13, 2023 | K223186 | Indigo® Aspiration System Lightning Bolt Aspiration Tubing Penumbra, Inc. | QEW |
| Feb 6, 2023 | K221531 | ClotTriever Thrombectomy System Inari Medical, Inc. | QEW |
| Jan 11, 2023 | K223000 | Artix BG Inari Medical | QEW |
| Dec 20, 2022 | K222358 | Indigo Aspiration System - Lightning Flash Penumbra, Inc. | QEW |
| Nov 10, 2022 | K221391 | WOLF Thrombectomy SmartClaw Catheter Devoro Medical, Inc. | QEW |
| Oct 4, 2022 | K220683 | INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) Penumbra, Inc. | QEW |
| Aug 4, 2022 | K220887 | Mini-ClotTriever Thrombectomy System Inari Medical | QEW |
| Jul 12, 2022 | K220415 | Protrieve Sheath Inari Medical, Inc. | QEW |
| Jun 23, 2022 | K221204 | Excipio SV Thrombectomy Device Contego Medical, Inc. | QEW |
| Jun 21, 2022 | K220270 | Aspirex Thrombectomy System C.R. Bard, Inc. | QEW |
| May 23, 2022 | K213402 | Triever24, Triever20 Inari Medical | QEW |
| Apr 6, 2022 | K214114 | Prodigy Thrombectomy System Truvic Medical, Inc. | QEW |
| Mar 25, 2022 | K220600 | Artix Thrombectomy Device Inari Medical | QEW |
| Mar 23, 2022 | K220501 | Pounce Thrombectomy System Surmodics,Inc. | QEW |
| Feb 24, 2022 | K211798 | Cleaner Plus Thrombectomy System Argon Medical Devices, Inc. | QEW |
| Oct 19, 2021 | K210911 | WOLF Thrombectomy System, 14F Devoro Medical, Inc. | QEW |
| Oct 18, 2021 | K212632 | ClotTriever Thrombectomy System Inari Medical, Inc. | QEW |
| Aug 27, 2021 | K210530 | WOLF Thrombectomy System, 6F Devoro Medical, Inc. | QEW |
| Jul 30, 2021 | K211492 | Pounce Thrombectomy System Surmodics,Inc. | QEW |
| May 12, 2021 | K210689 | ClotTriever Thrombectomy System Inari Medical, Inc. | QEW |
| Apr 30, 2021 | K211013 | FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 Inari Medical, Inc. | QEW |
| Feb 26, 2021 | K210323 | Indigo Aspiration System - Lightning Aspiration Tubing Penumbra, Inc. | QEW |
| Feb 24, 2021 | K210195 | Triever Catheters Inari Medical | QEW |
| Feb 23, 2021 | K210190 | ClotTriever Thrombectomy System Irani Medical, Inc. | QEW |
| Feb 9, 2021 | K210083 | Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 Penumbra, Inc. | QEW |
| Jan 15, 2021 | K201085 | NeVa PV Thrombectomy Device Vesalio | QEW |
| Dec 22, 2020 | K203476 | CAPERE Thrombectomy System Vascular Medcure, Inc. | QEW |
| Dec 22, 2020 | K201705 | ReVene Thrombectomy Catheter Vetex Medical, Ltd., IE | QEW |
| Dec 18, 2020 | K202345 | FlowTriever Retrieval/Aspiration System Inari Medical | QEW |
| Dec 10, 2020 | K203333 | Triever20 Curve Catheter Inari Medical, Inc. | QEW |
| Dec 4, 2020 | K201541 | FlowTriever Retrieval/Aspiration System Inari Medical | QEW |
| Nov 18, 2020 | K202821 | Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 Penumbra, Inc. | QEW |
| Oct 2, 2020 | K202218 | ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device Boston Scientific Corporation | QEW |
| Sep 21, 2020 | K192814 | Pounce Thrombus Retrieval System Surmodics,Inc. | QEW |
| Sep 9, 2020 | K193462 | ClotTriever Thrombectomy System Inari Medical | QEW |
| Aug 19, 2020 | K193595 | Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 Penumbra, Inc. | QEW |
| Jul 8, 2020 | K201216 | CAPERE Thrombectomy System Vascular Medcure, Inc. | QEW |
| May 28, 2020 | K192981 | Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 Penumbra, Inc. | QEW |
| Apr 27, 2020 | K200101 | WOLF Thrombectomy V System Devoro Medical, Inc. | QEW |
| Apr 22, 2020 | K200771 | Indigo Aspiration System Lightning Aspiration Tubing Penumbra, Inc. | QEW |
| Mar 13, 2020 | K193244 | Indigo Aspiration System Lightning Aspiration Tubing Penumbra, Inc. | QEW |
| Mar 4, 2020 | K200314 | Capere Thrombectomy System Vascular Medcure, Inc. | QEW |
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