Product code DQK— Cardiovascular
AcQMap High Resolution Imaging and Mapping System
- Advisory panel
- Cardiovascular
- Total cleared
- 434
Adverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DQK
1–100 of 434- K262006 — EnSite X EP System
- K252978 — ScioCardio ECG Analysis Platform
- K253463 — ILR ECG Analyzer (IM007)
- K261119 — NorthStar Mapping System (MAP01 or MAP01-01)
- K253088 — OneStim-DUO Cardiac Stimulator (MP5003-4CO)
- K261329 — Intra-Operative Positioning System (IOPS) (MC-1);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)
- K252859 — ZEUS Platform (FG0501US)
- K260212 — EnSite X EP System
- K253861 — ACORYS MAPPING SYSTEM
- K253473 — Synchrony
- K253186 — HemoSphere Nano Monitor (HSNANO1)
- K252972 — CARTO 3 EP Navigation System V8.4
- 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)
- K251591 — Holter ECG and ABP system (HolterABP)
- K251218 — SafeBeat Rx App
- K252164 — NorthStar Mapping System
- K254085 — CARTO 3 EP Navigation System V9.0 with PIU Plus
- K253733 — STAR Apollo Mapping System
- K252533 — HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)
- K253141 — DeepRhythmAI
- K252429 — Vektor Computational ECG Mapping System (vMap®)
- K252238 — CoroFlow Cardiovascular System
- K252645 — LumiGuide Equipment R2.1; LumiGuide Wire; LumiGuide 3D Hub
- K253034 — HemoSphere Stream Module
- K252013 — EnSite X EP System
- K251518 — Volta AF-Xplorer II
- K251463 — EnSite X EP System, AutoMark Index Software License (ENSITE-AMI-01); EnSite X EP System, AutoMark Index Temporary Software License (ENSITE-D-AMI-01)
- K252302 — CARTO 3 EP Navigation System V8.1
- K251234 — EnSite X EP System
- K243781 — HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2)
- K250747 — Globe® Pulsed Field System
- K250749 — PhysCade System
- K251344 — OptiMap System
- K250932 — DeepRhythmAI
- K243812 — Volta AF-Xplorer
- K242129 — VitalRhythm
- K243842 — Intra-Operative Positioning System (IOPS®)
- K243312 — CER-S
- K243892 — Affera Integrated Mapping System
- K243540 — Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)
- K243435 — Magnetic Localization Patch Kit (AFR-00021)
- K241197 — DeepRhythmAI
- K241828 — Affera Integrated Mapping System; Impedance Localization Patch Kit
- K242133 — Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)
- K241227 — RHYTHMIA HDx Mapping System
- K233755 — HeartKey® Rhythm
- K242016 — EnSite X EP System
- K240509 — STAR Apollo Mapping System
- K241243 — Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning System (IOPS®) Viewpoint (Double Curve Catheters)
- K233326 — Merge Hemo, Model RCSV2
- K233853 — LumiGuide Wire; LumiGuide Equipment R2.0; LumiGuide 3D Hub
- K233943 — Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)
- K231870 — CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System
- K233160 — NeuTrace EP Mapping System v.2.1
- K232294 — HemoSphere Alta Advanced Monitoring Platform; HemoSphere Alta Advanced Monitor (Smart Recovery); HemoSphere Alta Advanced Monitor (Cardiac); HemoSphere Alta Advanced Monitor (All-on-One)
- K232616 — Volta AF-Xplorer
- K230884 — AVVIGO'+ Multi-Modality Guidance System
- K223812 — Sensis Vibe (VD15)
- K231207 — CARTO 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)
- K230579 — Smart Wedge algorithm
- K231415 — EnSite X EP System
- K223787 — ECGenius System
- K231620 — Nuubo Smart
- K231035 — FusedCO Algorithm
- K231091 — AcQMap High Resolution Imaging and Mapping System
- K230309 — Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve Catheter (RCC-1); IOPS Guidewire (ATW-2); IOPS Tracking Pad (TP-1); IOPS Guidewire Handle (SSH-1)
- K223865 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor
- K223918 — AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub
- K230008 — Ablamap® System
- K230606 — AcQMap® High Resolution Imaging and Mapping System
- K223733 — CARTO® 3 EP Navigation System with CARTOSOUND 4D Version 7.4
- K222389 — ZEUS System
- K223516 — VX1+
- K211557 — EndoPATx
- K223094 — EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade; EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software License
- K220786 — STAR Apollo Mapping System
- K221704 — HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)
- K223127 — HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable
- K212493 — KODEX EPD System 1.5.0
- K222209 — AcQMap High Resolution Imaging and Mapping System
- K221213 — EnSite X EP System
- K221112 — CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)
- K210822 — DeepRhythmAI
- K213409 — ZEUS System (Zio Watch)
- K220784 — AcQMap High Resolution Imaging and Mapping System
- K213682 — HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote
- K220306 — ECGenius System
- K220243 — Ultiri Measurement System
- K212662 — AliveCor QT Service
- K213861 — CER-S
- K213972 — Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX
- K202094 — Cardiovascular Suite 4.2.1
- K213364 — EnSite X EP System
- K211546 — Vektor Computational ECG Mapping System (vMap)
- K210543 — IM007
- K213264 — CARTO 3 EP Navigation System Version 7.2
- K212061 — EnSite X EP System
- K212490 — AVVIGO Guidance System II
- K203084 — Ablamap Software
- K212345 — AcQMap High Resolution Imaging and Mapping System
Data sourced from openFDA. This site is unofficial and independent of the FDA.