FDA Product Code
FDA Product Code DQO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1200
510(k) Clearances — 501 records · page 1 of 6
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261455 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | 2026-06-26 | Traditional | PDF ↗ |
| K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N | Bioptimal International Pte. , Ltd. | 2026-05-28 | Traditional | PDF ↗ |
| K254278 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | 2026-03-25 | Special | PDF ↗ |
| K250751 | DualView Catheter | Terumo Corporation | 2025-07-17 | Traditional | PDF ↗ |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter | Gentuity, LLC | 2025-01-31 | Traditional | PDF ↗ |
| K242420 | pNOVUS 21 Microcatheter | Phenox, Ltd. | 2024-11-12 | Traditional | PDF ↗ |
| K233268 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | 2024-05-22 | Special | PDF ↗ |
| K233975 | Zoom 6F Insert Catheters | Imperative Care, Inc. | 2024-04-02 | Traditional | PDF ↗ |
| K232536 | Soldier Microcatheter | Embolx, Inc. | 2024-02-23 | Traditional | PDF ↗ |
| K232573 | INFINITI Ambi Angiographic Catheter | Cordis US Corp | 2023-11-21 | Traditional | PDF ↗ |
| K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter | Gentuity, LLC | 2023-08-08 | Traditional | PDF ↗ |
| K231293 | Drakon and Sequre® Microcatheters | Accurate Medical Therapeutics | 2023-06-01 | Special | PDF ↗ |
| K230411 | Dragonfly OpStar Imaging Catheter | ABBOTT MEDICAL | 2023-04-14 | Traditional | PDF ↗ |
| K221279 | pNOVUS 21 Microcatheter | Phenox, Ltd. | 2022-11-28 | Traditional | PDF ↗ |
| K213666 | NuCath Wedge Pressure Catheter | Pfm Medical, Inc. | 2022-10-06 | Traditional | PDF ↗ |
| K221470 | Langston dual lumen catheter | Vascular Solutions, LLC | 2022-06-17 | Special | PDF ↗ |
| K212977 | SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands | Cordis Corporation | 2022-02-17 | Traditional | PDF ↗ |
| K211078 | Progreat Lambda | Terumo Clinical Supply Co., Ltd. | 2021-12-21 | Traditional | PDF ↗ |
| K203487 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | 2020-12-11 | Special | PDF ↗ |
| K202797 | Drakon and Sequre Microcatheters | Accurate Medical Therapeutics, Ltd. | 2020-10-23 | Special | PDF ↗ |
| K193647 | Superpipe Angiographic Catheter | Suzhou Hengrui Disheng Medical Co., Ltd. | 2020-07-29 | Traditional | PDF ↗ |
| K192267 | ILUMIEN System with AptiVue Software version D.3 | ABBOTT MEDICAL | 2019-12-17 | Special | PDF ↗ |
| K192122 | Trevo Trak 21 Microcatheter | Stryker | 2019-11-22 | Traditional | PDF ↗ |
| K192019 | Dragonfly OpStar Imaging Catheter, AptiVue Software version E.5.1 | ABBOTT MEDICAL | 2019-11-08 | Traditional | PDF ↗ |
| K190126 | Bendit2.7 Steerable Microcatheter | Bend IT Technologies, Ltd. | 2019-08-22 | Traditional | PDF ↗ |
| K191608 | Impress Angiographic Catheter | Merit Medical Systems, Inc. | 2019-07-16 | Special | PDF ↗ |
| K181722 | Polyethylene Catheter | Cook Incorporated | 2019-03-22 | Traditional | PDF ↗ |
| K180846 | Arterial Pressure Monitoring Set/Tray | Cook Incorporated | 2018-12-19 | Traditional | PDF ↗ |
| K180792 | Arterial Pressure Monitoring Set/Tray | Cook Incorporated | 2018-11-30 | Traditional | PDF ↗ |
| K180286 | Polyethylene Catheter | Cook Incorporated | 2018-10-26 | Traditional | PDF ↗ |
| K180054 | Royal Flush Plus High-Flow Catheter | Cook Incorporated | 2018-10-05 | Traditional | PDF ↗ |
| K181836 | 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters | Cordis, A Cardinal Health Company | 2018-08-08 | Special | PDF ↗ |
| K173762 | AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters | AngioDynamics, Inc. | 2018-07-18 | Special | PDF ↗ |
| K172635 | High-Flo Silver Polyethylene Catheter | Cook Incorporated | 2018-04-03 | Traditional | PDF ↗ |
| K180677 | Surefire Spark Infusion System | Surefire Medical, Inc. | 2018-04-03 | Traditional | PDF ↗ |
| K173430 | SeQure® NF and SeQure® Microcatheters | Accurate Medical Therapeutics, Ltd. | 2018-01-26 | Traditional | PDF ↗ |
| K171264 | Royal Flush Catheter | Cook Incorporated | 2018-01-25 | Traditional | PDF ↗ |
| K170544 | Langston dual lumen catheter | Vascular Solutions, Inc. | 2017-11-17 | Traditional | PDF ↗ |
| K173289 | Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter | Cook Incorporated | 2017-11-15 | Special | PDF ↗ |
| K170223 | Progreat | Ashitaka Factory of Terumo Corporation | 2017-07-21 | Traditional | PDF ↗ |
| K162448 | White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter | Cook Incorporated | 2017-05-26 | Traditional | PDF ↗ |
| K171355 | Surefire Precision Infusion System | Surefire Medical, Inc. | 2017-05-17 | Special | PDF ↗ |
| K161596 | Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters | AngioDynamics, Inc. | 2017-04-28 | Traditional | PDF ↗ |
| K170406 | Plato MICROCATH 27B Microcatheter | Scientia Vascular, LLC | 2017-04-18 | Traditional | PDF ↗ |
| K162789 | Foresight Intracardiac Echocardiology (ICE) System | Conavi Medical, Inc. | 2017-03-28 | Traditional | PDF ↗ |
| K160660 | Medline Waste Station | Medline Industries, Inc. | 2017-01-19 | Traditional | PDF ↗ |
| K163141 | NAMIC ClearaCIL Contrast Injection Lines | AngioDynamics, Inc. | 2017-01-06 | Traditional | PDF ↗ |
| K161822 | Torcon NB Advantage Catheters | Cook Incorporated | 2016-10-27 | Special | PDF ↗ |
| K161287 | DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak | Medtronic Vascular | 2016-08-19 | Traditional | PDF ↗ |
| K160662 | Surefire Infusion System | Surefire Medical, Inc. | 2016-03-11 | Special | PDF ↗ |
| K153125 | IntraNovo Microcatheter | Texasmedical Technologies, Inc. | 2016-01-13 | Special | PDF ↗ |
| K151126 | Foresight Intracardiac Echocardiography (ICE) System | Colibri Technologies, Inc. | 2015-12-18 | Traditional | PDF ↗ |
| K152605 | Impulse Angiographic Catheter, Expo Angiographic Catheter | Boston Scientific Corporation | 2015-10-29 | Special | PDF ↗ |
| K150232 | Radifocus Optitorque Angiographic Catheter | Ashitaka Factory of Terumo Corp. | 2015-10-19 | Traditional | PDF ↗ |
| K151724 | AngioDynamics Mariner Angiographic Catheters | AngioDynamics, Inc. | 2015-10-14 | Special | PDF ↗ |
| K143398 | Plato MICROCATH 27B Microcatheter | Scientia Vascular, LLC | 2015-06-26 | Traditional | PDF ↗ |
| K143604 | Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters | Alvimedica Tibbi Urunler Sanayi VE Dis Ticaret A.S | 2015-06-25 | Traditional | PDF ↗ |
| K142817 | IntraNovo 25 Microcatheter | Texasmedical Technologies, Inc. | 2015-04-23 | Traditional | PDF ↗ |
| K140356 | SUMMED HIGH PRESSURE LINE | Sunny Medical Device (Shenzhen) Co., Ltd. | 2015-03-20 | Traditional | PDF ↗ |
| K143588 | Surefire Infusion System 021 | Surefire Medical, Inc. | 2015-01-12 | Traditional | PDF ↗ |
| K133130 | BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER | Cook, Inc. | 2015-01-09 | Traditional | PDF ↗ |
| K141453 | ILUMIEN OPTIS, DRAGONFLY OPTIS IMAGING CATHETER | Lightlab Imaging, Inc. | 2014-09-19 | Traditional | PDF ↗ |
| K141769 | OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER | Lightlab Imaging, Inc. | 2014-08-18 | Traditional | PDF ↗ |
| K131770 | PRESSURE CONNECTING TUBE | Shenzhen Ant Hi-Tech Industrial Co., Ltd. | 2014-02-26 | Traditional | PDF ↗ |
| K131437 | MODIFIED CONCENTRIC MICROCATHETER | Concentric Medical, Inc. | 2013-10-11 | Traditional | PDF ↗ |
| K123818 | URSA ANGIOGRAPHIC CATHETER | Curative Medical Technology, Inc. | 2013-03-04 | Special | PDF ↗ |
| K122937 | SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) | Cook, Inc. | 2012-12-14 | Special | PDF ↗ |
| K121694 | IMAGER II ANGIOGRAPHIC CATHETER | Boston Scientific Corp | 2012-09-14 | Traditional | PDF ↗ |
| K120008 | MEDLINE HIGH PRESSURE INJECTION TUBING | Medline Industries, Inc. | 2012-08-17 | Traditional | PDF ↗ |
| K120917 | HEADWAY DUO MICROCATHETER | MicroVention, Inc. | 2012-08-02 | Traditional | PDF ↗ |
| K121734 | PLATO MICROCATH 27 MICROCATHETER | Scientia Vascular, LLC | 2012-07-30 | Traditional | PDF ↗ |
| K121954 | NMI MICROCATHETER | Navilyst Medical, Inc. | 2012-07-17 | Special | PDF ↗ |
| K113335 | HEARTRAIL III GUIDING CATHETER | Terumo Corporation | 2012-07-16 | Special | PDF ↗ |
| K113819 | MONGOOSE ANGIOGRAPHIC CATHETER | Pediacath, Inc. | 2012-07-11 | Traditional | PDF ↗ |
| K121677 | SUREFIRE HI-FLOW MICROCATHETER | Surefire Medical, Inc. | 2012-06-14 | Traditional | PDF ↗ |
| K120495 | IMPULSE AND EXPO ANGIOGRAPHIC CATHETER | Boston Scientific Corp | 2012-05-21 | Special | PDF ↗ |
| K112452 | ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS | AngioDynamics, Inc. | 2012-03-30 | Special | PDF ↗ |
| K120893 | IMAGER II ANGIOGRAPHIC CATHETERS | Boston Scientific Corp | 2012-03-29 | Special | PDF ↗ |
| K113260 | MODIFIED CONCENTIRC MICROCATHETER | Concentric Medical, Inc. | 2012-03-09 | Special | PDF ↗ |
| K113737 | SUREFIRE GUIDE SHEATH | Surefire Medical, Inc. | 2012-02-23 | Special | PDF ↗ |
| K113638 | NMI 2.8 MICROCATHETER | Navilyst Medical, Inc. | 2012-01-05 | Special | PDF ↗ |
| K102633 | BIOTEQ ANGIOGRAPHIC CATHETER | Bioteque Corp. | 2011-09-09 | Traditional | PDF ↗ |
| K112124 | MICROCATHETER | Navilyst Medical, Inc. | 2011-08-19 | Abbreviated | PDF ↗ |
| K111619 | MODIFIED CONCENTRIC MICROCATHETER | Concentric Medical, Inc. | 2011-07-06 | Special | PDF ↗ |
| K110643 | MERIT MARQUIS FLOW SWITCH | Merit Medical Systems, Inc. | 2011-07-01 | Traditional | PDF ↗ |
| K110459 | SUREFIRE INFUSION CATHETER SYSTEM | Surefire Medical, Inc. | 2011-06-24 | Traditional | PDF ↗ |
| K110103 | EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER | Edwards Lifesciences, LLC | 2011-02-11 | Special | PDF ↗ |
| K101625 | COHEN CROSSOVER CATHETER | Vascular Solutions, Inc. | 2010-07-19 | Traditional | PDF ↗ |
| K101669 | THERMODILUTION CATHETER | Biosensors Intl. Pte. , Ltd. | 2010-07-01 | Special | PDF ↗ |
| K101239 | VIEWFLEX PLUS ICE CATHETER | St Jude Medical | 2010-06-02 | Special | PDF ↗ |
| K093004 | IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING | Merit Medical Systems, Inc. | 2010-02-12 | Traditional | PDF ↗ |
| K090427 | URSA ANGIOGRAPHIC CATHETER | Curative Medical Technology, Inc. | 2010-01-29 | Traditional | PDF ↗ |
| K092118 | ANGIOGRAPHIC CATHETER, MODEL ANGIOS | Oscor, Inc. | 2010-01-13 | Traditional | PDF ↗ |
| K083384 | THERMODILUTION CATHETER | Biosensors Intl. Pte. , Ltd. | 2010-01-05 | Special | PDF ↗ |
| K092702 | MICRUS MICROCATHETER, MODEL COURIER 270 | Micrus Endovascular Corporation | 2009-11-20 | Special | PDF ↗ |
| K091780 | GUIDED MEASUREMENT CATHETER (GMC) | Mediguide, Ltd. | 2009-10-16 | Traditional | PDF ↗ |
| K092372 | HEARTRAIL III GUIDING CATHETER | Terumo Corp. | 2009-09-11 | Traditional | PDF ↗ |
| K091961 | MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047 | Concentric Medical, Inc. | 2009-07-30 | Special | PDF ↗ |
| K083922 | MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00 | Micrus Endovascular Corporation | 2009-05-06 | Special | PDF ↗ |
| K090276 | ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM | Siemens Medical Solutions USA, Inc. | 2009-02-19 | Traditional | PDF ↗ |
Product code DQO · Class II · Cardiovascular. Data: openFDA.