Panels › Cardiovascular › Product code DQO · Class 2
Catheter, Intravascular, Diagnostic
Regulation 870.1200
3510(k)s in 12 months (501 all time)
26recalls in 12 months (285 all time)
246recalls that name a 510(k)
Top companies in DQO
| Company | 510(k)s | Recalls |
|---|---|---|
| Cook Incorporated | 15 | 85 |
| Boston Scientific Corp | 20 | 73 |
| Merit Medical Systems, Inc. | 8 | 33 |
| Cordis Corp. | 29 | 8 |
| AngioDynamics, Inc. | 11 | 23 |
| Vascular Solutions, Inc. | 12 | 10 |
| C.R. Bard, Inc. | 16 | 0 |
| Scimed Life Systems, Inc. | 16 | 0 |
| LeMaitre Vascular, Inc. | 0 | 12 |
| Target Therapeutics | 10 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 26, 2026 | K261455 | Arterial Pressure Monitoring Set/Tray Spectrum Vascular | DQO |
| May 28, 2026 | K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD250 Bioptimal International Pte. , Ltd., SG | DQO |
| Mar 25, 2026 | K254278 | Arterial Pressure Monitoring Set/Tray Spectrum Vascular | DQO |
| Jul 17, 2025 | K250751 | DualView Catheter Terumo Corporation, JP | DQO |
| Jan 31, 2025 | K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter Gentuity, LLC | DQO |
| Nov 12, 2024 | K242420 | pNOVUS 21 Microcatheter Phenox, Ltd., IE | DQO |
| May 22, 2024 | K233268 | Impress Angiographic Catheter Merit Medical Systems, Inc. | DQO |
| Apr 2, 2024 | K233975 | Zoom 6F Insert Catheters Imperative Care, Inc. | DQO |
| Feb 23, 2024 | K232536 | Soldier Microcatheter Embolx, Inc. | DQO |
| Nov 21, 2023 | K232573 | INFINITI Ambi Angiographic Catheter Cordis US Corp | DQO |
| Aug 8, 2023 | K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter Gentuity, LLC | DQO |
| Jun 1, 2023 | K231293 | Drakon and Sequre® Microcatheters Accurate Medical Therapeutics, IL | DQO |
| Apr 14, 2023 | K230411 | Dragonfly OpStar Imaging Catheter ABBOTT MEDICAL | DQO |
| Nov 28, 2022 | K221279 | pNOVUS 21 Microcatheter Phenox, Ltd., IE | DQO |
| Oct 6, 2022 | K213666 | NuCath Wedge Pressure Catheter Pfm Medical, Inc. | DQO |
| Jun 17, 2022 | K221470 | Langston dual lumen catheter Vascular Solutions, LLC | DQO |
| Feb 17, 2022 | K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands Cordis Corporation | DQO |
| Dec 21, 2021 | K211078 | Progreat Lambda Terumo Clinical Supply Co., Ltd., JP | DQO |
| Dec 11, 2020 | K203487 | Drakon and Sequre Microcatheters Accurate Medical Therapeutics, Ltd., IL | DQO |
| Oct 23, 2020 | K202797 | Drakon and Sequre Microcatheters Accurate Medical Therapeutics, Ltd., IL | DQO |
| Jul 29, 2020 | K193647 | Superpipe Angiographic Catheter Suzhou Hengrui Disheng Medical Co., Ltd., CN | DQO |
| Dec 17, 2019 | K192267 | ILUMIEN System with AptiVue Software version D.3 ABBOTT MEDICAL | DQO |
| Nov 22, 2019 | K192122 | Trevo Trak 21 Microcatheter Stryker | DQO |
| Nov 8, 2019 | K192019 | Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1 ABBOTT MEDICAL | DQO |
| Aug 22, 2019 | K190126 | Bendit2.7 Steerable Microcatheter Bend IT Technologies, Ltd., IL | DQO |
| Jul 16, 2019 | K191608 | Impress Angiographic Catheter Merit Medical Systems, Inc. | DQO |
| Mar 22, 2019 | K181722 | Polyethylene Catheter Cook Incorporated | DQO |
| Dec 19, 2018 | K180846 | Arterial Pressure Monitoring Set/Tray Cook Incorporated | DQO |
| Nov 30, 2018 | K180792 | Arterial Pressure Monitoring Set/Tray Cook Incorporated | DQO |
| Oct 26, 2018 | K180286 | Polyethylene Catheter Cook Incorporated | DQO |
| Oct 5, 2018 | K180054 | Royal Flush Plus High-Flow Catheter Cook Incorporated | DQO |
| Aug 8, 2018 | K181836 | 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters Cordis, A Cardinal Health Company | DQO |
| Jul 18, 2018 | K173762 | AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters AngioDynamics, Inc. | DQO |
| Apr 3, 2018 | K180677 | Surefire Spark Infusion System Surefire Medical, Inc. | DQO |
| Apr 3, 2018 | K172635 | High-Flo Silver Polyethylene Catheter Cook Incorporated | DQO |
| Jan 26, 2018 | K173430 | SeQure® NF and SeQure® Microcatheters Accurate Medical Therapeutics, Ltd., IL | DQO |
| Jan 25, 2018 | K171264 | Royal Flush Catheter Cook Incorporated | DQO |
| Nov 17, 2017 | K170544 | Langston dual lumen catheter Vascular Solutions, Inc. | DQO |
| Nov 15, 2017 | K173289 | Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Cook Incorporated | DQO |
| Jul 21, 2017 | K170223 | Progreat Ashitaka Factory of Terumo Corporation, JP | DQO |
| May 26, 2017 | K162448 | White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter Cook Incorporated | DQO |
| May 17, 2017 | K171355 | Surefire Precision Infusion System Surefire Medical, Inc. | DQO |
| Apr 28, 2017 | K161596 | Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters AngioDynamics, Inc. | DQO |
| Apr 18, 2017 | K170406 | Plato MICROCATH 27B Microcatheter Scientia Vascular, LLC | DQO |
| Mar 28, 2017 | K162789 | Foresight Intracardiac Echocardiology (ICE) System Conavi Medical, Inc., CA | DQO |
| Jan 19, 2017 | K160660 | Medline Waste Station Medline Industries, Inc. | DQO |
| Jan 6, 2017 | K163141 | NAMIC ClearaCIL Contrast Injection Lines AngioDynamics, Inc. | DQO |
| Oct 27, 2016 | K161822 | Torcon NB Advantage Catheters Cook Incorporated | DQO |
| Aug 19, 2016 | K161287 | DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak Medtronic Vascular | DQO |
| Mar 11, 2016 | K160662 | Surefire Infusion System Surefire Medical, Inc. | DQO |
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