FDA Review Panel · CV

FDA 510(k) Cardiovascular Devices

FDA 510(k) Cardiovascular Devices - Regulatory Overview

FDA 510(k) cardiovascular devices represent one of the largest device categories, with 17,947 submissions since 1976. The FDA review panel code is CV.

This category covers a wide risk spectrum:

  • Class I / II - blood pressure monitors, stethoscopes, ECG systems, holter monitors
  • Class II Special Controls - catheters, guidewires, cardiac ablation systems
  • Class II / III - pacemakers, implantable defibrillators, stents

Top product codes include DXN (blood pressure systems, 1,201 devices) and DQY (percutaneous catheters, 850 devices). Average FDA review time: 125 days.

18110
Total
18057
Cleared
149d
Avg (2y)
1976
Since
14804 Cardiovascular devices
5351–5375 of 14804
Cleared Jul 09, 2010
U-RIGHT TD-3127 BLOOD PRESSURE MONITORING SYSTEM
K100658 · Taidoc Technology Corporation
DXN · System, Measurement, Blood-pressure, Non-invasive · 123d
Cleared Jul 09, 2010
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM
K092853 · Galix Biomedical Instrumentation, Inc.
MLO · Electrocardiograph, Ambulatory, With Analysis Algorithm · 296d
Cleared Jul 08, 2010
HI-TORQUE WINN GUIDE WIRE FAMILY
K101648 · Abbott Vascular, Inc.
DQX · Wire, Guide, Catheter · 27d
Cleared Jul 08, 2010
IMPELLA CONTROLLER
K093801 · Abiomed, Inc.
KFM · Pump, Blood, Cardiopulmonary Bypass, Non-roller Type · 210d
Cleared Jul 02, 2010
ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT)
K101667 · St Jude Medical
DQK · Computer, Diagnostic, Programmable · 18d
Cleared Jul 02, 2010
ELI 250 ELECTROCARDIOGRAPH
K101403 · Mortara Instrument, Inc.
DPS · Electrocardiograph · 44d
Cleared Jul 02, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR , MODEL KN-550
K100620 · Harvard Medical Devices , Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 120d
Cleared Jul 01, 2010
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, WATCHBP OFFICE TARGET (BP3MD1-4).
K101512 · Microlife Intellectual Property GmbH
DXN · System, Measurement, Blood-pressure, Non-invasive · 30d
Cleared Jul 01, 2010
RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26
K093877 · Edwards Lifesciences, LLC
DYB · Introducer, Catheter · 197d
Cleared Jun 30, 2010
LIPISCAN IVUS IMAGING SYSTEM MODEL NIRS-MC7-70
K093993 · Infraredx, Inc.
OGZ · Catheter, Intravascular, Plaque Morphology Evaluation · 188d
Cleared Jun 29, 2010
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965
K100940 · Andon Health Co, Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 85d
Cleared Jun 25, 2010
CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR
K101639 · Card Guard Scientific Survival , Ltd.
DSI · Detector And Alarm, Arrhythmia · 15d
Cleared Jun 25, 2010
ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
K101431 · C.R. Bard, Inc.
DTK · Filter, Intravascular, Cardiovascular · 35d
Cleared Jun 22, 2010
WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY AND AUTO ID MODEL: D-1263-04,
K101345 · Biosense Webster, Inc.
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 40d
Cleared Jun 22, 2010
SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12
K101138 · Biosense Webster, Inc.
OBJ · Catheter, Ultrasound, Intravascular · 61d
Cleared Jun 22, 2010
AFFIITY CP CENTRIFUGAL BLOOD PUMP
K100631 · Medtronic, Inc.
KFM · Pump, Blood, Cardiopulmonary Bypass, Non-roller Type · 109d
Cleared Jun 18, 2010
INTELLIVUE PATIENT MONITOR
K101449 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 25d
Cleared Jun 18, 2010
ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150
K101115 · Mortara Instrument, Inc.
DPS · Electrocardiograph · 58d
Cleared Jun 18, 2010
MULTIFUNCTIONAL LINEAR PEN
K100501 · AtriCure, Inc.
OCL · Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue · 116d
Cleared Jun 18, 2010
CARTO XP EP NAVIGATION SYSTEM, VERSION 10
K093566 · Biosense Webster, Inc.
DQK · Computer, Diagnostic, Programmable · 212d
Cleared Jun 18, 2010
LASSO NAV CATHETER
K093376 · Biosense Webster, Inc.
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 232d
Cleared Jun 18, 2010
PULSION PICCO2 (8500), CEVOX OPTICAL MODULE (PC3015), CEVOX DISPOSABLE PROBES (PV2022-30 THRU -38, PV2022-46 THRU -48)
K091786 · Pulsion Medical Systems AG
DXG · Computer, Diagnostic, Pre-programmed, Single-function · 366d
Cleared Jun 17, 2010
V-TRUST TD-8002 MULTI-PARAMETER SPOT-CHECK MONITOR MODEL TD-8002
K101259 · Taidoc Technology Corporation
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 44d
Cleared Jun 17, 2010
HASKAL TORQUE DEVICE
K100425 · Elcam Medical Acal
DQX · Wire, Guide, Catheter · 121d
Cleared Jun 11, 2010
ENSITE VELOCITY SYSTEM, MODEL EE3000
K101419 · St Jude Medical
DQK · Computer, Diagnostic, Programmable · 22d

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All categories 14804 DXN System, Measurement, Blood-pressure, Non-invasive 926 DQY Catheter, Percutaneous 786 DQX Wire, Guide, Catheter 698 DYB Introducer, Catheter 629 DPS Electrocardiograph 437 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 409 DQO Catheter, Intravascular, Diagnostic 400 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 375 LIT Catheter, Angioplasty, Peripheral, Transluminal 358 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 336 DSI Detector And Alarm, Arrhythmia 306 JOW Sleeve, Limb, Compressible 273 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 268