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
14964 Cardiovascular devices
8076–8100 of 14964
Cleared Feb 19, 2002
SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER
K020277 · Siemens Medical Solutions USA, Inc.
DRQ · Amplifier And Signal Conditioner, Transducer Signal · 22d
Cleared Feb 15, 2002
A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS
K012472 · A&D Engineering, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 197d
Cleared Feb 15, 2002
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K020144 · Siemens Medical Solutions USA, Inc.
DRT · Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · 30d
Cleared Feb 12, 2002
BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T
K010452 · Koven Technology, Inc.
DPW · Flowmeter, Blood, Cardiovascular · 362d
Cleared Feb 12, 2002
COBE REVOLUTION
K011835 · Cobe Cardiovascular, Inc.
KFM · Pump, Blood, Cardiopulmonary Bypass, Non-roller Type · 245d
Cleared Feb 12, 2002
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE E.0
K014261 · Philips Medical Systems, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 47d
Cleared Feb 11, 2002
SOLAR 8000M SYSTEM
K012467 · General Electric Medical Systems Information Techn
DSI · Detector And Alarm, Arrhythmia · 194d
Cleared Feb 11, 2002
STERILMED REPROCESSED COMPRESSION SLEEVES
K012597 · Sterilmed, Inc.
JOW · Sleeve, Limb, Compressible · 185d
Cleared Feb 11, 2002
MODIFICATION TO TRANSSEPTAL INTRODUCER SET
K020090 · Thomas Medical Products, Inc.
DYB · Introducer, Catheter · 32d
Cleared Feb 11, 2002
BACK-UP MEIER STEERABLE GUIDEWIRE
K020283 · Boston Scientific Corp
DQX · Wire, Guide, Catheter · 14d
Cleared Feb 06, 2002
VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07
K011540 · Datascope Corp.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 264d
Cleared Feb 06, 2002
FUKUDA DENSHI DYNASCOPE MODEL DS-5700
K020084 · Fukuda Denshi USA, Inc.
DSI · Detector And Alarm, Arrhythmia · 27d
Cleared Feb 05, 2002
VASCUPUNCTURE ACCESS WIRE
K012861 · Neometrics, Inc.
DQX · Wire, Guide, Catheter · 165d
Cleared Feb 01, 2002
TM2000, MODEL 1
K013879 · Card Guard Scientific Survival , Ltd.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 70d
Cleared Feb 01, 2002
ENGUARD CHC DUAL RESERVOIR CARDIOPLEGIA HEATER/COOLER
K014016 · Minntech Corp.
DWC · Controller, Temperature, Cardiopulmonary Bypass · 58d
Cleared Feb 01, 2002
DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410
K020022 · Ge Medical Systems Information Technologies
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 29d
Cleared Jan 25, 2002
CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C
K013392 · Medtronic Vascular
OCL · Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue · 102d
Cleared Jan 25, 2002
ULTRAMAX WOVEN VELOUR VASCULAR GRAFT
K013577 · Atrium Medical Corp.
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 88d
Cleared Jan 24, 2002
HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K012534 · Advanced Cardiovascular Systems, Inc.
DQX · Wire, Guide, Catheter · 171d
Cleared Jan 23, 2002
KION ANAESTHESIA SYSTEM, MODEL 65 03 879 E392E
K010923 · Siemens Elema AB
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 302d
Cleared Jan 23, 2002
PORTABLE INTENSIVE CARE UNIT
K012766 · Medical Research Laboratories, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 159d
Cleared Jan 22, 2002
VANGUARD REPROCESSED INFLATION DEVICES
K012480 · Vanguard Medical Concepts, Inc.
MAV · Syringe, Balloon Inflation · 173d
Cleared Jan 22, 2002
PUMP TUBING
K013578 · Terumo Cardiovascular Systems Corp.
DWE · Tubing, Pump, Cardiopulmonary Bypass · 85d
Cleared Jan 22, 2002
6F MACH1/34356-XXX
K020028 · Boston Scientific
DQY · Catheter, Percutaneous · 18d
Cleared Jan 18, 2002
PHILLIPS M1175A/76A/77A COMPONENT MONITORING SYSTEM
K014159 · Philips Medical Systems, Inc.
DSI · Detector And Alarm, Arrhythmia · 30d

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All categories 14964 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