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.

18027
Total
17975
Cleared
150d
Avg (2y)
1976
Since
4324 Cardiovascular devices
1676–1700 of 4324
Cleared Nov 20, 2020
MPS 3 ND Myocardial Protection System
K201984 · Quest Medical, Inc.
DTR · Heat-exchanger, Cardiopulmonary Bypass · 126d
Cleared Nov 19, 2020
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
K203008 · Cardiovascular Systems, Inc.
MCW · Catheter, Peripheral, Atherectomy · 49d
Cleared Nov 18, 2020
Indigo Aspiration System - Aspiration Catheter 12 and Separator 12
K202821 · Penumbra, Inc.
QEW · Peripheral Mechanical Thrombectomy With Aspiration · 55d
Cleared Nov 18, 2020
Pacific Plus PTA Catheter
K202800 · Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC)
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 56d
Cleared Nov 17, 2020
JETi AIO Peripheral Thrombectomy System
K201998 · Walk Vascular, LLC
QEZ · Aspiration Thrombectomy Catheter · 120d
Cleared Nov 17, 2020
R501 aortic root cannula without vent line, R502 aortic root cannula with vent line
K200612 · Sorin Group Italia S.R.L.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 253d
Cleared Nov 16, 2020
Cordiana Dx16
K201060 · Cordiana Medical Informatics AG
DQK · Computer, Diagnostic, Programmable · 209d
Cleared Nov 13, 2020
FlexCath Advance Steerable Sheath and Dilator
K202620 · Medtronic Cryocath, LP
DRA · Catheter, Steerable · 64d
Cleared Nov 13, 2020
CoroFlow Cardiovascular System
K201881 · Coroventis Research AB
DQK · Computer, Diagnostic, Programmable · 129d
Not Cleared Nov 13, 2020
Acumen Assisted Fluid Management (AFM) Software Feature
DEN190029 · Edwards Lifesciences
QMS · Adjunctive Open Loop Fluid Therapy Recommender · 529d
Cleared Nov 12, 2020
NOVA Patient Warming System
K203085 · Encompass Group, LLC
DWJ · System, Thermal Regulating · 30d
Cleared Nov 12, 2020
KardiaAI
K201985 · AliveCor, Inc.
DQK · Computer, Diagnostic, Programmable · 118d
Cleared Nov 06, 2020
SimpleSENSE
K201669 · Nanowear, Inc.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 140d
Cleared Nov 05, 2020
LOBO Vascular Occlusion System (model LOBO-5)
K203025 · Okami Medical
KRD · Device, Vascular, For Promoting Embolization · 34d
Cleared Nov 04, 2020
Monitor B125, Monitor B105
K201941 · Ge Medical Systems Information Technologies, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 114d
Cleared Oct 30, 2020
eKuore Pro Series
K203007 · Chip Ideas Electronics S.L.
DQD · Stethoscope, Electronic · 29d
Cleared Oct 30, 2020
Aulisa Multiple Patient Digital Vital Sign Monitoring System
K202497 · Taiwan Aulisa Medical Devices Technologies, Inc.
MSX · System, Network And Communication, Physiological Monitors · 60d
Cleared Oct 30, 2020
Patent Hemostasis Band (PH Band)
K201695 · Medical Ingenuities
DXC · Clamp, Vascular · 130d
Cleared Oct 30, 2020
Smart Alarm Interface
K193421 · Boxview, LLC
MSX · System, Network And Communication, Physiological Monitors · 326d
Cleared Oct 30, 2020
eCordum Cardiac Monitor (eCordum CM)
K193296 · Ecordum, Inc.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 338d
Cleared Oct 26, 2020
coraForce and coraFlex Support Catheters
K201811 · Reflow Medical, Inc.
DQY · Catheter, Percutaneous · 117d
Cleared Oct 23, 2020
Drakon and Sequre Microcatheters
K202797 · Accurate Medical Therapeutics, Ltd.
DQO · Catheter, Intravascular, Diagnostic · 30d
Cleared Oct 23, 2020
OXY-1 System
K200109 · Abiomed, Inc.
DTZ · Oxygenator, Cardiopulmonary Bypass · 280d
Cleared Oct 16, 2020
Quantum Ventilation Module
K202733 · Spectrum Medical , Ltd.
DTX · Gas Control Unit, Cardiopulmonary Bypass · 28d
Cleared Oct 16, 2020
Selectra 3D Outer Guiding Catheters
K193474 · Biotronik, Inc.
DQY · Catheter, Percutaneous · 305d

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All categories 4324 DXN System, Measurement, Blood-pressure, Non-invasive 241 DQY Catheter, Percutaneous 233 DYB Introducer, Catheter 194 DQX Wire, Guide, Catheter 188 DTB Permanent Pacemaker Electrode 187 DQK Computer, Diagnostic, Programmable 165 LIT Catheter, Angioplasty, Peripheral, Transluminal 138 DXY Implantable Pacemaker Pulse-generator 133 DQO Catheter, Intravascular, Diagnostic 121 QEW Peripheral Mechanical Thrombectomy With Aspiration 118 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 103 JOW Sleeve, Limb, Compressible 86 DPS Electrocardiograph 80 DTZ Oxygenator, Cardiopulmonary Bypass 71 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 69