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.

18151
Total
18097
Cleared
152d
Avg (2y)
1976
Since
14981 Cardiovascular devices
8401–8425 of 14981
Cleared Sep 18, 2000
QUEST MPS BACK-UP SYSYEM
K002366 · Quest Medical, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 53d
Cleared Sep 18, 2000
HL168T
K002750 · Health & Life Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 13d
Cleared Sep 15, 2000
NICORE MODEL ESP -1
K980937 · Nicore Equipment & Leasing, Inc.
DRN · Device, Counter-pulsating, External · 918d
Cleared Sep 13, 2000
COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K002591 · Cobe Cardiovascular, Inc.
DTP · Defoamer, Cardiopulmonary Bypass · 23d
Cleared Sep 13, 2000
PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
K992476 · Pilling Weck Surgical
MWS · Stabilizer, Heart · 415d
Cleared Sep 11, 2000
GOLDEN-RULE SCALING CATHETER
K002416 · Medical Device Technologies, Inc.
DQO · Catheter, Intravascular, Diagnostic · 34d
Cleared Sep 08, 2000
HEARTSTREAM XL DEFIBRILLATOR/MONITOR, MODEL M4735A
K001725 · Agilent Technologies, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 94d
Cleared Sep 07, 2000
CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE
K000830 · California Medical Laboratories, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 177d
Cleared Sep 06, 2000
BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020
K000743 · Boston Scientific Scimed, Inc.
DQO · Catheter, Intravascular, Diagnostic · 183d
Cleared Sep 06, 2000
AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
K001149 · Augustine Medical, Inc.
DWJ · System, Thermal Regulating · 149d
Cleared Sep 06, 2000
CAPIOX ARTERIAL FILTER
K002026 · Terumo Medical Corp.
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 65d
Cleared Sep 06, 2000
S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE
K002158 · Datex-Ohmeda, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 51d
Cleared Aug 31, 2000
LIFE SCOPE EC, MODEL BSM-1102
K000517 · Nihon Kohden America, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 197d
Cleared Aug 31, 2000
GAZELLE BALLOON DILATATION CATHETER
K001134 · Boston Scientific Corp
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 143d
Cleared Aug 31, 2000
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
K002333 · Biosense Webster, Inc.
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 30d
Cleared Aug 31, 2000
ROTAFLOW CENTRIFUGAL PUMP SYSTEM
K991864 · Jostra Medizintechnik AG
KFM · Pump, Blood, Cardiopulmonary Bypass, Non-roller Type · 457d
Cleared Aug 25, 2000
DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET
K002365 · Datascope Corp.
DYB · Introducer, Catheter · 22d
Cleared Aug 24, 2000
HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO
K002206 · Guidant Corp.
DQX · Wire, Guide, Catheter · 34d
Cleared Aug 22, 2000
CAPIOX SX HARDSHELL RESERVOIR WITH X-COATING
K002238 · Terumo Cardiovascular Systems Corp.
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 29d
Cleared Aug 18, 2000
GE MARQUETTE ECG ANALYSIS PROGRAM
K002209 · General Electric Medical Systems Information Techn
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 28d
Cleared Aug 18, 2000
CAMBRIDGE HEART MICRO-V ALTERNANS SENSOR, MODEL 20327-002
K002230 · Cambridge Heart, Inc.
DRX · Electrode, Electrocardiograph · 25d
Cleared Aug 16, 2000
GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300
K001969 · Medtronic Vascular
DQY · Catheter, Percutaneous · 49d
Cleared Aug 16, 2000
SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX
K993698 · Mogul Enterprises
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 288d
Cleared Aug 15, 2000
V QUICK PATCH
K993934 · Vq Corp.
DRX · Electrode, Electrocardiograph · 271d
Cleared Aug 11, 2000
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
K993875 · Boston Medical Technologies, Inc.
DPS · Electrocardiograph · 270d

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All categories 14981 DXN System, Measurement, Blood-pressure, Non-invasive 942 DQY Catheter, Percutaneous 792 DQX Wire, Guide, Catheter 702 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