FDA Review Panel · CV

FDA 510(k) Cardiovascular Devices

About Cardiovascular Devices

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.

18004
Total
17953
Cleared
125d
Avg days
1976
Since
1063 Cardiovascular devices
1001–1025 of 1063
Cleared Aug 26, 2021
ViperCross Support Catheters
K211240 · Cardiovascular Systems, Inc.
DQY · Catheter, Percutaneous · 122d
Cleared Aug 24, 2021
TurboHawk Plus Directional Atherectomy System
K212027 · Medtronic, Inc.
MCW · Catheter, Peripheral, Atherectomy · 56d
Cleared Aug 13, 2021
WATCHMAN FXD Curve Access System
K212228 · Boston Scientific Corporation
DQY · Catheter, Percutaneous · 28d
Cleared Aug 12, 2021
Crosser iQ CTO Recanalization System
K203363 · C.R. Bard, Inc.
PDU · Catheter For Crossing Total Occlusions · 269d
Cleared Aug 05, 2021
AcQMap High Resolution Imaging and Mapping System
K210680 · Acutus Medical, Inc.
DQK · Computer, Diagnostic, Programmable · 150d
Cleared Jul 30, 2021
Wrist Blood Pressure Monitor, Blood Pressure Monitor
K210768 · Andon Health Co, Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 137d
Cleared Jul 30, 2021
Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform
K203224 · Edwards Lifesciences, LLC
QAQ · Adjunctive Predictive Cardiovascular Indicator · 270d
Cleared Jul 29, 2021
Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor
K210770 · Andon Health Co, Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 136d
Cleared Jul 27, 2021
Aveir Introducer
K211989 · Abbott Medical
DYB · Introducer, Catheter · 29d
Cleared Jul 26, 2021
AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
K210477 · AtriCure, Inc.
OCL · Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue · 157d
Cleared Jul 22, 2021
Reveal LINQ Insertable Cardiac Monitor
K212008 · Medtronic, Inc.
MXD · Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) · 24d
Cleared Jul 22, 2021
FlowSaver Blood Filter
K210176 · Inari Medical
CAC · Apparatus, Autotransfusion · 181d
Cleared Jul 19, 2021
Z-6 Atrioseptostomy Catheter
K211910 · NuMED, Inc.
DXF · Catheter, Septostomy · 28d
Cleared Jul 16, 2021
SwiftNINJA Steerable Microcatheter
K211525 · Merit Medical Systems, Inc.
KRA · Catheter, Continuous Flush · 60d
Cleared Jul 15, 2021
Bio-Medicus Life Support Catheter and Introducer
K201100 · Medtronic, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 447d
Cleared Jul 12, 2021
EOS PMP
K211495 · Sorin Group Italia S.R.L.
DTZ · Oxygenator, Cardiopulmonary Bypass · 60d
Cleared Jul 12, 2021
Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables
K203556 · Medtronic, Inc.
DSA · Cable, Transducer And Electrode, Patient, (including Connector) · 217d
Cleared Jun 30, 2021
Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph
K210560 · Philips Medical Systems
DPS · Electrocardiograph · 125d
Cleared Jun 25, 2021
iLab Polaris Multi-Modality Guidance System
K210889 · Boston Scientific Corporation
DQK · Computer, Diagnostic, Programmable · 92d
Cleared Jun 11, 2021
LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System
K210484 · Medtronic, Inc.
MXD · Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) · 112d
Cleared Jun 08, 2021
OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
K210458 · Abbott Medical
NQQ · System, Imaging, Optical Coherence Tomography (oct) · 112d
Cleared Jun 04, 2021
AlphaVac Multipurpose Mechanical Aspiration (MMA) System
K211081 · AngioDynamics, Inc.
QEZ · Aspiration Thrombectomy Catheter · 53d
Cleared Jun 03, 2021
Breezeway II
K210627 · Oscor, Inc.
DYB · Introducer, Catheter · 93d
Cleared May 28, 2021
AtriCure Isolator® Synergy™ Surgical Ablation System
K211311 · AtriCure, Inc.
OCL · Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue · 28d
Cleared May 28, 2021
LINQ II Insertable Cardiac Monitor
K211304 · Medtronic, Inc.
MXD · Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) · 29d

Looking for a specific cardiovascular device? Search by device name, K-number or manufacturer.

Search all Cardiovascular 510(k) devices
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All categories 1063 DXN System, Measurement, Blood-pressure, Non-invasive 84 DQK Computer, Diagnostic, Programmable 73 DYB Introducer, Catheter 68 QEW Peripheral Mechanical Thrombectomy With Aspiration 63 DQY Catheter, Percutaneous 61 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 39 DQX Wire, Guide, Catheter 37 DPS Electrocardiograph 24 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 22 JOW Sleeve, Limb, Compressible 19 OBJ Catheter, Ultrasound, Intravascular 19 KRD Device, Vascular, For Promoting Embolization 18 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 17 MXD Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) 17 DRF Catheter, Electrode Recording, Or Probe, Electrode Recording 15