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
14963 Cardiovascular devices
7976–8000 of 14963
Cleared Jul 26, 2002
ILT ADVANCING MECHANISM, MODEL A115AMI
K021638 · Intra Luminal Therapeutics, Inc.
DQX · Wire, Guide, Catheter · 67d
Cleared Jul 24, 2002
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU02 AND L-ICU02A SOFTWARE
K021376 · Datex-Ohmeda
DSI · Detector And Alarm, Arrhythmia · 84d
Cleared Jul 19, 2002
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANE02 AND L-ANE02A SOFTWARE
K021279 · Datex-Ohmeda
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 88d
Cleared Jul 18, 2002
REPROCESSED FEMORAL COMPRESSION DEVICE
K012574 · Sterilmed, Inc.
NMF · Clamp, Vascular, Reprocessed · 343d
Cleared Jul 16, 2002
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
K022149 · Cambridge Heart, Inc.
DPS · Electrocardiograph · 14d
Cleared Jul 16, 2002
HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
K022152 · Cambridge Heart, Inc.
DPS · Electrocardiograph · 14d
Cleared Jul 12, 2002
ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711
K021874 · Abbott Laboratories
DXG · Computer, Diagnostic, Pre-programmed, Single-function · 35d
Cleared Jul 11, 2002
ILT TORQUER, MODEL 114TR1
K021243 · Intra Luminal Therapeutics, Inc.
DQX · Wire, Guide, Catheter · 83d
Cleared Jul 10, 2002
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072
K021899 · Concentric Medical, Inc.
DQY · Catheter, Percutaneous · 30d
Cleared Jul 09, 2002
EASI 12 LEAD ALGORITHM
K020456 · Philips Medical Systems
DRW · Adaptor, Lead Switching, Electrocardiograph · 148d
Cleared Jul 09, 2002
BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
K021473 · Augustine Medical, Inc.
DWJ · System, Thermal Regulating · 62d
Cleared Jul 03, 2002
INTROCAN SAFETY IV CATHETER
K021094 · B.Braun Medical, Inc.
DYB · Introducer, Catheter · 90d
Cleared Jul 03, 2002
MAC-LAB/CARDIOLAB EP/COMBOLAB
K021366 · General Electric Medical Systems Information Techn
DQK · Computer, Diagnostic, Programmable · 64d
Cleared Jul 03, 2002
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL #M4735A
K021453 · Philips Medical Systems
MKJ · Automated External Defibrillators (non-wearable) · 58d
Cleared Jul 02, 2002
MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000
K013205 · Millar Instruments, Inc.
DRQ · Amplifier And Signal Conditioner, Transducer Signal · 280d
Cleared Jul 02, 2002
DINAMAP PROCARE SERIES MONITOR
K014255 · Ge Medical Systems Information Technologies
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 188d
Cleared Jul 02, 2002
SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
K021830 · Cobe Cardiovascular, Inc.
DTR · Heat-exchanger, Cardiopulmonary Bypass · 28d
Cleared Jun 28, 2002
QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52
K021097 · Spacelabs Medical, Inc.
DSI · Detector And Alarm, Arrhythmia · 85d
Cleared Jun 27, 2002
H12+HOLTER RECORDER
K021373 · Mortara Instrument, Inc.
MWJ · Electrocardiograph, Ambulatory (without Analysis) · 57d
Cleared Jun 27, 2002
WELCH ALLYN ABPM 6100
K021756 · Welch Allyn, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 29d
Cleared Jun 26, 2002
JUMP START, MODEL 970300
K021168 · Medical Research Laboratories, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 76d
Cleared Jun 24, 2002
M2376 DEVICELINK SYSTEM
K021912 · Philips Medical Systems, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 13d
Cleared Jun 20, 2002
EQUALIZER BALLOON CATHETER
K021721 · Boston Scientific Corp
DQY · Catheter, Percutaneous · 27d
Cleared Jun 18, 2002
MODIFICATION TO HYPERGLIDE OCCLUSION BALLOON SYSTEM
K021066 · Micro Therapeutics, Inc.
MJN · Catheter, Intravascular Occluding, Temporary · 77d
Cleared Jun 13, 2002
MODIFICATION TO ENVOY AND VISTA BRITE TIP
K021593 · Cordis Corp.
DQY · Catheter, Percutaneous · 29d

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All categories 14963 DXN System, Measurement, Blood-pressure, Non-invasive 939 DQY Catheter, Percutaneous 792 DQX Wire, Guide, Catheter 701 DYB Introducer, Catheter 638 DPS Electrocardiograph 443 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 413 DQO Catheter, Intravascular, Diagnostic 404 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 377 LIT Catheter, Angioplasty, Peripheral, Transluminal 365 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 339 DSI Detector And Alarm, Arrhythmia 310 JOW Sleeve, Limb, Compressible 288 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 275