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
14744 Cardiovascular devices
4401–4425 of 14744
Cleared Mar 22, 2013
MORTARA SURVEYOR PATIENT MONITOR
K123556 · Mortara Instrument, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 123d
Cleared Mar 22, 2013
FEMORAL ACCESS VENOUS CANNULAE
K123303 · Edwards Lifesciences, LLC
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 150d
Cleared Mar 22, 2013
PROCARE MONITOR B20
K122253 · Ge Medical Systems China Co., Ltd.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 238d
Cleared Mar 21, 2013
BP652N (HEM-6300-Z)
K123498 · Omron Healthcare, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 128d
Cleared Mar 21, 2013
APPS-HEALTH01
K122098 · Andon Health Co, Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 248d
Cleared Mar 20, 2013
INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE
K130433 · Sorin Group Italia S.R.L.
DTZ · Oxygenator, Cardiopulmonary Bypass · 27d
Cleared Mar 20, 2013
CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER
K130257 · St Jude Medical
DQY · Catheter, Percutaneous · 47d
Cleared Mar 20, 2013
CPS AIM UNIVERSAL SLITTABLE INNER CATHETER
K130252 · St Jude Medical
DQY · Catheter, Percutaneous · 47d
Cleared Mar 20, 2013
LIDCORAPID V2 MONITOR
K122247 · Lidco, Ltd.
DXG · Computer, Diagnostic, Pre-programmed, Single-function · 236d
Cleared Mar 19, 2013
GUIDEZILLA GUIDE EXTENSION CATHETER
K123765 · Boston Scientific
DQY · Catheter, Percutaneous · 102d
Cleared Mar 19, 2013
VIA MICROCATHETER, VIA PLUS MICROCATHETER
K123477 · Sequent Medical, Inc.
KRA · Catheter, Continuous Flush · 126d
Cleared Mar 19, 2013
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
K123351 · Medtronic Perfusion Systems
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 139d
Cleared Mar 19, 2013
ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3
K122940 · Cook, Inc.
DQY · Catheter, Percutaneous · 176d
Cleared Mar 15, 2013
FLIXENE IFG VASCULAR GRAFT
K130142 · Atrium Medical Corporation
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 52d
Cleared Mar 15, 2013
FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING
K123298 · Edwards Lifesciences, LLC
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 143d
Cleared Mar 15, 2013
TVC IMAGING SYSTEM MODEL NIRS-MC7-70
K123108 · Infraredx, Inc.
OGZ · Catheter, Intravascular, Plaque Morphology Evaluation · 163d
Cleared Mar 14, 2013
CATALYST II AND III
K130124 · Cardiva Medical, Inc.
DXC · Clamp, Vascular · 56d
Cleared Mar 13, 2013
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
K130520 · Ashitaka Factory of Terumo Corp.
DTZ · Oxygenator, Cardiopulmonary Bypass · 13d
Cleared Mar 13, 2013
CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR
K130493 · Terumo Corporation
DTZ · Oxygenator, Cardiopulmonary Bypass · 15d
Cleared Mar 13, 2013
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR, CAPIOX SX25 HOLLOW FIBER OXGENATOR WITH DETACHA
K130359 · Terumo Cardiovascular Systems Corp.
DTZ · Oxygenator, Cardiopulmonary Bypass · 28d
Cleared Mar 13, 2013
CAPIX RX HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR
K130333 · Terumo Cardiovascular Systems Corp.
DTZ · Oxygenator, Cardiopulmonary Bypass · 30d
Cleared Mar 13, 2013
CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR
K130280 · Terumo Corporation
DTZ · Oxygenator, Cardiopulmonary Bypass · 36d
Cleared Mar 13, 2013
NUVON VITALS CHARTING SYSTEM
K130234 · Nuvon, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 42d
Cleared Mar 13, 2013
EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA
K123370 · Edwards Lifesciences, LLC
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 132d
Cleared Mar 12, 2013
HEARSTART MRX WITH AIRWAY CONFIMRATION ASSIST
K130153 · Philips Medical Systems
MKJ · Automated External Defibrillators (non-wearable) · 49d

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All categories 14744 DXN System, Measurement, Blood-pressure, Non-invasive 919 DQY Catheter, Percutaneous 782 DQX Wire, Guide, Catheter 694 DYB Introducer, Catheter 626 DPS Electrocardiograph 436 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 407 DQO Catheter, Intravascular, Diagnostic 400 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 375 LIT Catheter, Angioplasty, Peripheral, Transluminal 357 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 336 DSI Detector And Alarm, Arrhythmia 305 JOW Sleeve, Limb, Compressible 271 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 265