Review Panel
Cardiovascular FDA 510(k) Clearances & Devices
- Cleared Devices
- 19,212
- Product Codes (page)
- 46
- Latest Decision
- 2026-04-23
Clearances · page 3 of 193
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K253589 | Liberant RX Aspiration Catheter | Medtronic Interventional Vascular, Inc. | QEZ | Class II | 2026-04-23 |
| K250793 | RhythmStar System (SL) | RhythMedix, LLC | QYX | Class II | 2026-04-21 |
| K253982 | Korotkoff sound blood pressure monitor | Beijing Hanvon Health Technology Co., Ltd. | DXN | Class II | 2026-04-21 |
| K254046 | BosCATH Support Catheter | Sonorous NV, Inc. | QJP | Class II | 2026-04-21 |
| K260212 | EnSite X EP System | ABBOTT MEDICAL | DQK | Class II | 2026-04-20 |
| K254279 | Edwards eSheath+ introducer set | Edwards Lifesciences | DYB | Class II | 2026-04-17 |
| DEN250033 | XplantR Explant Tool | Hjarta Care, LLC | SHR | Class II | 2026-04-17 |
| K252945 | Novasight Hybrid System | Conavi Medical, Inc. | OBJ | Class II | 2026-04-17 |
| K252317 | Zenith Micro Guidewire | Suzhou Zenith Vascular SciTech Limited | MOF | Class II | 2026-04-16 |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | MHX | Class II | 2026-04-16 |
| K254223 | Next Generation 088 Catheter | Balt USA, LLC | QJP | Class II | 2026-04-16 |
| K253048 | High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer Tube | Shenzhen Maiwei Biotech Co., Ltd. | DXT | Class II | 2026-04-16 |
| K260903 | Hot Pink Pad Warming System | Xodus Medical, Inc. | DWJ | Class II | 2026-04-16 |
| K260938 | PATH BGC | Crossroads Neurovascular, Inc. | QJP | Class II | 2026-04-15 |
| K260931 | Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) | Unimed Medical Supplies, Inc. | DQA | Class II | 2026-04-14 |
| K260498 | TriMemo SEMIRIGID ANNULOPLASTY RING | Corcym S.r.l. | KRH | Class II | 2026-04-14 |
| K260091 | Aventus Introducer Sheath | Inquis Medical | DYB | Class II | 2026-04-13 |
| K253861 | ACORYS MAPPING SYSTEM | Corify Care S.L | DQK | Class II | 2026-04-13 |
| K253361 | Teleport Glide Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | DQY | Class II | 2026-04-10 |
| K260244 | Auryon Atherectomy System | Eximo Medical | MCW | Class II | 2026-04-10 |
| K252250 | Vista 300/Vista 300 S; Vista 300 Non-Inv Model A, US (2601064); Vista 300 Invasive Model C, US (2601065); Vista 300 S Non-Inv Model A, US (2602425); Vista 300 S Invasive Model B, US (2602426); Vista 300 S Invasive Model C, US (2602427) | Shanghai Draeger Medical Instrument Co., Ltd. | MHX | Class II | 2026-04-10 |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001) | Protaryx Medical, Inc. | DYB | Class II | 2026-04-10 |
| K260508 | LOBO Vascular Occlusion System | Okami Medical, Inc. | KRD | Class II | 2026-04-10 |
| K253975 | Radical 6F Access Catheter | Maduro Medical, Inc. | QJP | Class II | 2026-04-09 |
| K260816 | OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090) | Boston Scientific | OBJ | Class II | 2026-04-08 |
| K260942 | AuST Steerable Sheath | CenterPoint Systems, LLC | DYB | Class II | 2026-04-07 |
| K252861 | Warming System | Hangzhou Tappa Medical Technology Co., Ltd. | DWJ | Class II | 2026-04-07 |
| K252116 | Firefighter Pro PTCA Balloon Catheter | Shanghai MicroPort Medical (Group) Co., Ltd. | LOX | Class II | 2026-04-07 |
| K253801 | ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) | Anumana, Inc. | SHP | Class II | 2026-04-07 |
| K260459 | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | DYB | Class II | 2026-04-06 |
| K254066 | Etiometry Platform | Etiometry, Inc. | PPW | Class II | 2026-04-03 |
| K254060 | Life Saving Tourniquet | TW Medical | DXC | Class II | 2026-04-03 |
| K254022 | FLASH Flex Aorto-Ostial Angioplasty System | Verge Medical, Inc. | LOX | Class II | 2026-04-02 |
| K260276 | Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro | Shenzhen AOJ Medical Technology Co., Ltd. | DXN | Class II | 2026-04-01 |
| K253473 | Synchrony | Stereotaxis, Inc. | DQK | Class II | 2026-04-01 |
| K254225 | Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) | Shenzhen HanHan Technology Co., Ltd. | DXN | Class II | 2026-04-01 |
| K253654 | IntelliVue Measurement Rack 6000 (867317) | Philips Medizin Systeme Böblingen GmbH | MSX | Class II | 2026-03-30 |
| K252360 | ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) | Anumana, Inc. | SAT | Class II | 2026-03-28 |
| K252295 | Ryurei | Terumo Corporation | LOX | Class II | 2026-03-27 |
| K260626 | Multiflex Steerable Sheath 17.5F | Vizaramed, Inc. | DYB | Class II | 2026-03-26 |
| K260273 | Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) | Shenzhen Urion Technology Co., Ltd. | DXN | Class II | 2026-03-26 |
| K254278 | Arterial Pressure Monitoring Set/Tray | Spectrum Vascular | DQO | Class II | 2026-03-25 |
| K254208 | FLOWRUNNER Aspiration System | Expanse Medical, Inc. | QEZ | Class II | 2026-03-20 |
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 | FMD Co., Ltd. | DQX | Class II | 2026-03-20 |
| K260437 | Valvuloplasty Balloon Catheter (ValvuloPro) | Dongguan TT Medical, Inc. | OZT | Class II | 2026-03-20 |
| K253746 | Enroute 0.014'' Transcarotid Guidewire | Lake Region Medical | DQX | Class II | 2026-03-19 |
| K260537 | Willow 24 Guidewire | Arbor Endovascular, LLC | MOF | Class II | 2026-03-19 |
| K260188 | LimFlow Vector | LimFlow, Inc. | MGZ | Class II | 2026-03-18 |
| K253590 | Millipede System | Perfuze, Ltd. | NRY | Class II | 2026-03-16 |
| K252122 | DCwire Micro-guidewire | Shanghai Achieva Medical Suzhou Co., Ltd. | MOF | Class II | 2026-03-16 |
| K253838 | Lifemotion Disposable Membrane Oxygenator | Lifemotion Medical Technology Co., Ltd. | DTZ | Class II | 2026-03-16 |
| K253799 | SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R) | Pressure Products Medical Device Manufacturing, LLC | DXF | Class II | 2026-03-13 |
| K260499 | Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 | ABBOTT MEDICAL | DQY | Class II | 2026-03-13 |
| K253205 | OptiMap Catheter - 50mm (OPTI-CATH2-50) | Cortex, Inc. | MTD | Class II | 2026-03-13 |
| K253062 | Tigertriever 25 Revascularization Device | Rapid Medical Ltd. | NRY | Class II | 2026-03-12 |
| K240934 | Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3); | Spectrum Medical S.R.L. | DTZ | Class II | 2026-03-12 |
| K252541 | Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W | Spectrum Medical S.R.L. | DTR | Class II | 2026-03-12 |
| K250794 | InVera Infusion Device | Invera Medical | KRA | Class II | 2026-03-12 |
| K252089 | Tyto Stethoscope (G3) | Tyto Care , Ltd. | DQD | Class II | 2026-03-12 |
| K250937 | Venous Return Cannulae | LivaNova USA, Inc. | DWF | Class II | 2026-03-11 |
| K253262 | EmeryGlide (EG18008901) | Nano4imaging GmbH | DQX | Class II | 2026-03-06 |
| K251788 | Extension tube | Zhuhai DR Medical Instruments Co., Ltd. | DXT | Class II | 2026-03-05 |
| K252779 | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | DXN | Class II | 2026-03-05 |
| K252448 | AViTA Pulse Oximeter (SP61) | Avita Corporation | DQA | Class II | 2026-02-27 |
| K260292 | HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) | Atraverse Medical | DXF | Class II | 2026-02-27 |
| K253186 | HemoSphere Nano Monitor (HSNANO1) | Edwards Lifesciences, LLC | DQK | Class II | 2026-02-24 |
| K254267 | NanoPress 760A-BT (760A-BT) | Mego Afek , Ltd. | JOW | Class II | 2026-02-24 |
| K260043 | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) | Smart Reactors | DWF | Class II | 2026-02-23 |
| K253228 | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | DXN | Class II | 2026-02-23 |
| K252972 | CARTO 3 EP Navigation System V8.4 | Biosense Webster, Inc. | DQK | Class II | 2026-02-20 |
| K260163 | AuST CSP Introducer | CenterPoint Systems, LLC | DYB | Class II | 2026-02-19 |
| K253203 | Retrograde Coronary Sinus Perfusion Cannulae | Medtronic, Inc. | DWF | Class II | 2026-02-19 |
| K260149 | Versus Catheter (VS110-9NB) | Liquet Medical, Inc. | QEY | Class II | 2026-02-17 |
| K254089 | IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035) | Centerline Biomedical, Inc. | DQK | Class II | 2026-02-17 |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. | DQA | Class II | 2026-02-17 |
| K252512 | Armada 14 NC PTA Catheter | ABBOTT MEDICAL | LIT | Class II | 2026-02-13 |
| K251581 | Wearable Ambulatory Blood Pressure Monitor (WBP-02A) | Shenzhen Hingmed Medical Instrument Co., Ltd. | DXN | Class II | 2026-02-13 |
| K250233 | PreemptiveAI Clinical SDK | Measure Labs, Inc. (Dba Preemptiveai, Inc.) | DXH | Class II | 2026-02-13 |
| K253133 | Wrist Blood Pressure Monitor (BPM-W1VL) | Shenzhen Imdk Medical Technology Co., Ltd. | DXN | Class II | 2026-02-13 |
| K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) | Bayer Medical Care, Inc. | DXT | Class II | 2026-02-13 |
| K252685 | Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) | Joytech Healthcare Co. , Ltd. | DXN | Class II | 2026-02-13 |
| K253089 | NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) | Shenzhen Best Electronics Co., Ltd. | DXQ | Class II | 2026-02-13 |
| K260130 | Willow 18 Guidewire | Arbor Endovascular, LLC | MOF | Class II | 2026-02-13 |
| K253092 | Argos Infinity (Rev. 1.0) | Retia Medical Systems, Inc. | DXG | Class II | 2026-02-13 |
| K253032 | AXS Lift Intracranial Base Catheter | Stryker Neurovascular | QJP | Class II | 2026-02-11 |
| K251591 | Holter ECG and ABP system (HolterABP) | Edan Instruments, Inc. | DQK | Class II | 2026-02-09 |
| K254236 | Peel-Away Introducer Sheath | VascuTech Medical, LLC | DYB | Class II | 2026-02-09 |
| K252726 | IntelliVue Multi-Measurement Module X3 (867030); IntelliVue Patient Monitor MX100 (867033); IntelliVue MMX (867036) | Philips Medizin Systeme Boeblingen GmbH | MHX | Class II | 2026-02-06 |
| K252076 | Kneevoice Cartilage Evaluation System (750-3600-001) | Kneevoice, Inc. | DQD | Class II | 2026-02-06 |
| K251218 | SafeBeat Rx App | SafeBeat Rx, Inc. | DQK | Class II | 2026-02-06 |
| K260028 | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister | Argon Medical Devices, Inc. | QEW | Class II | 2026-02-05 |
| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK | Penumbra, Inc. | QEW | Class II | 2026-02-05 |
| K260012 | UltraScore Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | PNO | Class II | 2026-02-04 |
| K252676 | The Circadia C300 System (C300) | Circadia Health, Inc. | DRT | Class II | 2026-02-03 |
| K252011 | CHIKAI Nexus petit | Asahi Intecc Co., Ltd. | MOF | Class II | 2026-02-02 |
| K251200 | Vital Signs | Oxehealth Limited | QME | Class II | 2026-02-02 |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) | Merit Medical Ireland, Ltd. | DQX | Class II | 2026-01-31 |
| K253671 | Dual Stage Venous Cannulae | Sorin Group Italia S.R.L. | DWF | Class II | 2026-01-30 |
| K253388 | Sleepiz One+ (Model 2.5) | Sleepiz AG | DRT | Class II | 2026-01-28 |
| K253224 | MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) | ImpediMed Limited | OBH | Class II | 2026-01-28 |
19,212 clearances in the Cardiovascular panel. Data: openFDA.