Product code DRF— Cardiovascular
IntellaMap Orion High Resolution Mapping Catheter
- Advisory panel
- Cardiovascular
- Total cleared
- 185
Adverse events under product code DRF
product code DRF- Death
- 127
- Injury
- 1,676
- Malfunction
- 2,003
- Other
- 1
- Total
- 3,807
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 DRF
1–100 of 185- K252794 — Vision-MR Diagnostic Catheter
- K250590 — MAGiC Sweep EP Mapping Catheter
- K250310 — VIKING Fixed Curve Diagnostic Catheter
- K240366 — EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter
- K233900 — Nordica PV Cryo Mapping Catheter
- K233397 — Cosine-10TM Diagnostic Catheter
- K233207 — Polaris X Unidirectional Steerable Diagnostic Catheter
- K232651 — BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter
- K230503 — Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable
- K210313 — EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter
- K220796 — IntellaMap Orion High Resolution Mapping Catheter
- K203793 — RithmID-SD Steerable Diagnostic Electrophysiology Catheter
- K211327 — Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters
- K211219 — LASSOSTAR NAV Circular Mapping Catheter
- K212593 — ViaCath, AcQRate Dx Steerable Catheter
- K211494 — Polaris X Unidirectional Steerable Diagnostic Catheter
- K211375 — Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter
- K201445 — MultiCath, AcQRate Dx Fixed Curve Catheter
- K203261 — Reprocessed Inquiry Steerable Diagnostic EP Catheter
- K193632 — LassoStar Circular Mapping Catheter
- K191880 — Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter
- K192360 — IntellaMap Orion High Resolution Mapping Catheter
- K192037 — Advisor VL Circular Mapping Catheter, Sensor Enabled
- K183547 — Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
- K190132 — Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter
- K190980 — Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
- K183632 — Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable
- K183649 — Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable
- K182386 — Reprocessed Supreme Diagnostic Electrophysiology Catheter
- K171277 — Reprocessed Inquiry Steerable Diagnostic EP Catheter
- K160335 — Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D
- K161769 — Reprocessed Supreme Diagnostic Electrophysiology Catheters
- K162892 — Achieve Advance Mapping Catheter
- K151139 — EasyMap MAP Catheter
- K153139 — Achieve ST Mapping Catheter, Catheter Connecting Cable
- K160390 — Map-it Diagnostic Mapping Catheters
- K151622 — St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter
- K150631 — St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter
- K143481 — IntellaMap Orion High Resolution Mapping Catheter
- K133028 — RITHM ID ELECTROPHYSIOLOGY CATHETER
- K130602 — LASSO NAV DUO LOOP CATHETER
- K122461 — RHYTHMIA MAPPING CATHETER
- K120544 — RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN
- K113213 — LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM LINE 2
- K101991 — WEBSTER DUO-DECAPOLAR CATHETER
- K102588 — ACHIEVE MAPPING CATHETER AND ELECTRICAL CABLE
- K102721 — LIVEWIRE ELECTOPHYSIOLOGY CATHETER
- K101955 — ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058
- K101623 — INQUIRY AFOCUSII DIAGNOSTIC CATHETER
- K101345 — WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,
- K093376 — LASSO NAV CATHETER
- K090898 — CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS CATHETER WITH EZ STEER
- K091370 — RADIA STEERABLE DIAGNOSTIC CATHETER
- K081803 — ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM
- K090120 — REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03, REFSTAR PLUS CABLE, MODEL M-4700-106
- K081576 — BLAZER DX-20 DIAGNOSTIC CATHETER
- K080179 — REFLEXION HD HIGH-DENSITY MAPPING CATHETER
- K081258 — VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02
- K082061 — INQUIRY H-CURVE TV STEERABLE DIAGNOSTIC CATHETER
- K080425 — CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02
- K072012 — REFLEXION SPIRAL VARIABLE RADIUS CATHETER
- K061678 — PRORHYTHM PROMAP COAXIAL MAPPING CATHETER, MODELS PRI-MAP-15, PRI-MAP-20, PRI-MAP-25
- K062251 — REFLEXION SPIRAL VARIABLE RADIUS CATHETER, MODEL 402804
- K061463 — ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S
- K061468 — REFSTAR EXTERNAL REFERENCE PATCH
- K060047 — CARTO RMT EP NAVIGATION SYSTEM V8
- K060757 — INQUIRY OPTIMA PLUS STEERABLE ELECTROPHYSIOLOGY CATHETER
- K053582 — INQUIRY AFOCUS II DIAGNOSTIC CATHETER
- K042998 — REFSTAR RMT EXTERNAL REFERENCE PATCH
- K052083 — NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER
- K050877 — CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR
- K043257 — REAL-TIME POSITION MANAGEMENT (RPM) SYSTEM
- K042775 — INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER
- K042105 — CLIPPER DIAGNOSTIC ELECTRODE CATHETER
- K033963 — EP DEFLECTABLE CATHETERS
- K033050 — EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2
- K030627 — ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110
- K031161 — VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER
- K030852 — 4 FRENCH & 5 FRENCH ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS MODELS 5UEXXX, 5BEXXX AND 5FEXXX, AND 4UEXXX, 4BEXXX AND 4FEX
- K021421 — PADTAC ELECTROPHYSIOLOGY RECORDING CATHETERS, JUNCTION CABLE CONNECTOR & CABLE
- K022380 — LIVESIRE ELECTROPHYSIOLOGY CATHETER
- K013484 — TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH
- K012520 — GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL-20E
- K011361 — DESAI VECTORCATH MAPPING CATHETER, DESAI VECTORCATH CONNECTOR CABLE
- K011847 — ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE
- K011734 — 6-FRENCH, 20-ELECTRODE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER, MODELS 6U20XXX, 6B20XXX, AND 6F20XXX
- K011766 — 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722; 6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027
- K010471 — AFOCUS ELECTROPYSIOLOGY CATHETER SYSTEM, MODELS 81550, 81567, 81568, 81569
- K002976 — RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX
- K003452 — POLARIS X CATHETERS, MODEL 7000D,7001D,7003D,7004D,7005D,7006D
- K002333 — BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
- K993698 — SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX
- K000753 — CORDIS 13F CATHETER SHEATH INTRODUCER
- K991060 — ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000
- K992912 — CARDIAC PATHWAYS REFERENCE CATHETER AND REFERENCE CATHETER WITH TRACKING, CARDIAC PATHWAYS RADII CATHETER AND RADII CATH
- K991878 — LUMA-CATH STEERABLE EP CATHETERS
- K992965 — CORDIS WEBSTER FIXED CURVE CATHETERS, MODELS D-1124, D-1085
- K992373 — ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE
- K991025 — LUMA-CATH FIXED CURVE EP CATHETERS
- K991531 — CORDIS WEBSTER DIAGNOSTIC DEFLECTABLE TIP CATHETER, MODEL D-1078
Data sourced from openFDA. This site is unofficial and independent of the FDA.