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
4339 Cardiovascular devices
2576–2600 of 4339
Cleared Dec 13, 2017
Advocate PTA Catheter
K173621 · Merit Medical Systems, Inc.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 21d
Cleared Dec 13, 2017
True Flow Valvuloplasty Perfusion Catheter
K172932 · C.R. Bard, Inc.
OZT · Balloon Aortic Valvuloplasty · 78d
Cleared Dec 01, 2017
Octane aspiration system
K173266 · Vascular Solutions, Inc.
QEZ · Aspiration Thrombectomy Catheter · 51d
Cleared Nov 30, 2017
HeRO Graft
K172637 · Merit Medical Systems, Inc.
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 90d
Cleared Nov 20, 2017
Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface
K172984 · Medtronic, Inc.
DTZ · Oxygenator, Cardiopulmonary Bypass · 54d
Cleared Nov 17, 2017
Performer Introducer
K173068 · Cook Incorporated
DYB · Introducer, Catheter · 49d
Cleared Nov 17, 2017
Duravess bovine pericardial vascular patch
K172660 · Edwards Lifesciences, LLC
PSQ · Intracardiac Patch Or Pledget, Biologically Derived · 73d
Cleared Nov 17, 2017
Masimo Root Monitoring System and Accessories
K171121 · Masimo Corporation
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 214d
Cleared Nov 17, 2017
Langston dual lumen catheter
K170544 · Vascular Solutions, Inc.
DQO · Catheter, Intravascular, Diagnostic · 266d
Cleared Nov 16, 2017
OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU)
K173284 · Boston Scientific Corporation
OBJ · Catheter, Ultrasound, Intravascular · 31d
Cleared Nov 15, 2017
Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter
K173289 · Cook Incorporated
DQO · Catheter, Intravascular, Diagnostic · 30d
Cleared Nov 15, 2017
uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)
K171901 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 142d
Cleared Nov 13, 2017
CXI TriForce Peripheral Crossing Set
K170931 · Cook Incorporated
KRA · Catheter, Continuous Flush · 229d
Cleared Nov 09, 2017
WATCHDOG Hemostasis Valve Kit
K172453 · Boston Scientific Corporation
DQX · Wire, Guide, Catheter · 87d
Cleared Nov 09, 2017
MX40 Release B.07
K172226 · Philips Medical Systems
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 107d
Cleared Nov 03, 2017
Fixed Patient Leads ECG Cable (Model 3153)
K172591 · Boston Scientific Corporation
DSA · Cable, Transducer And Electrode, Patient, (including Connector) · 66d
Cleared Nov 02, 2017
myMerlin(TM) Mobile Application Model APP1001
K173232 · St Jude Medical
MXC · Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) · 29d
Cleared Oct 27, 2017
Tubing Pack
K171979 · Medtronic, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 119d
Cleared Oct 25, 2017
Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir
K172626 · Medtronic, Inc.
DTZ · Oxygenator, Cardiopulmonary Bypass · 54d
Cleared Oct 25, 2017
Gel-Bead
K171946 · Vascular Solutions, Inc.
KRD · Device, Vascular, For Promoting Embolization · 118d
Cleared Oct 23, 2017
TruWave Disposable Pressure Transducer
K171996 · Edwards Lifesciences, LLC
DXO · Transducer, Pressure, Catheter Tip · 112d
Cleared Oct 20, 2017
GuideLiner V3 Catheter
K172090 · Vascular Solutions, Inc.
DQY · Catheter, Percutaneous · 101d
Cleared Oct 18, 2017
Liberator Beacon Tip Locking Stylet
K170298 · Cook Incorporated
DRB · Stylet, Catheter · 260d
Cleared Oct 12, 2017
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump
K172305 · Datascope Corp.
DSP · System, Balloon, Intra-aortic And Control · 73d
Cleared Oct 10, 2017
3M Bair Hugger Model 675 Total Temperature Management System
K171373 · 3M Company
DWJ · System, Thermal Regulating · 153d

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All categories 4339 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 134 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 72 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 71