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
14795 Cardiovascular devices
5176–5200 of 14795
Cleared Mar 11, 2011
FUKUDA DENSHI
K103134 · Fukuda Denshi USA, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 137d
Cleared Mar 11, 2011
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
K102919 · Maquet Cardiopulmonary, AG
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 161d
Cleared Mar 11, 2011
MERIT EMBOLECTOMY CATHETER MODEL ASAP100
K100569 · Merit Medical Systems, Inc.
QEZ · Aspiration Thrombectomy Catheter · 375d
Cleared Mar 10, 2011
AIRSTRIP REMOTE PATIENT MONITORING (RPM)
K110503 · Airstrip Technologies, LP
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 16d
Cleared Mar 08, 2011
ZOLL R SERIES WITH 2010 AHA GUIDELINES SOFTWARE UPDATE
K110361 · Zoll Medical Corporation, World Wide Headquarters
MKJ · Automated External Defibrillators (non-wearable) · 29d
Cleared Mar 08, 2011
QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING
K103191 · Maquet Cardiopulmonary, AG
DTZ · Oxygenator, Cardiopulmonary Bypass · 131d
Cleared Mar 07, 2011
ASAHI GUIDE WIRE EXTENSION 165CM
K101985 · Asahi Intecc Co., Ltd.
DQX · Wire, Guide, Catheter · 236d
Cleared Mar 04, 2011
QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING
K102464 · Maquet Cardiopulmonary, AG
DTZ · Oxygenator, Cardiopulmonary Bypass · 189d
Cleared Mar 03, 2011
INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM
K110295 · Boston Scientific Corp
KRD · Device, Vascular, For Promoting Embolization · 30d
Cleared Mar 03, 2011
INTERLOCK FIBERED IDC OCCLUSION SYSTEM
K102912 · Boston Scientific
KRD · Device, Vascular, For Promoting Embolization · 153d
Cleared Mar 03, 2011
MEDLINE ANGIOGRAPHIC CONTROL SYRINGE
K093830 · Medline Industries, Inc.
DXT · Injector And Syringe, Angiographic · 444d
Cleared Mar 02, 2011
SPAULDING IQ ELECTROCARDIOGRAPH
K110065 · Spaulding Clinical Research, LLC
DPS · Electrocardiograph · 51d
Cleared Mar 02, 2011
INPECTRA STO2 SPOT CHECK
K103613 · Hutchinson Technology, Inc.
MUD · Oximeter, Tissue Saturation · 83d
Cleared Mar 01, 2011
V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER
K101569 · Taidoc Technology Corporation
DPS · Electrocardiograph · 270d
Cleared Feb 25, 2011
ENDOLOGIX GUIDEWIRE
K110241 · Techdevice Corporation
DQX · Wire, Guide, Catheter · 29d
Cleared Feb 25, 2011
APPROACH PRO ST WIRE GUIDE
K110163 · Cook Incorporated
DQX · Wire, Guide, Catheter · 37d
Cleared Feb 25, 2011
HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
K102532 · Maquet Cardiopulmonary, AG
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 175d
Cleared Feb 24, 2011
FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH
K110193 · St. Jude Medical Systems AB
DXC · Clamp, Vascular · 31d
Cleared Feb 23, 2011
ASCOM CLINICALCONNEX CARDIOMAX
K103634 · Ascom (Us), Inc.
MSX · System, Network And Communication, Physiological Monitors · 72d
Cleared Feb 23, 2011
EBONY PTA .035 PERIPHERAL DILATATION CATHETER
K103354 · Natec Medical , Ltd.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 99d
Cleared Feb 23, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-931
K102939 · Andon Health Co, Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 142d
Cleared Feb 18, 2011
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR
K110330 · Andon Health Co, Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 15d
Cleared Feb 18, 2011
PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
K110167 · Edwards Lifesciences, LLC
DQE · Catheter, Oximeter, Fiber-optic · 29d
Cleared Feb 18, 2011
SYNTHES SCOUT VESSEL GUARD
K103558 · Synthes Spine
OMR · Vessel Guard Or Cover · 78d
Cleared Feb 18, 2011
VASCULAR POSITIONING SYSTEM (VPS SYSTEM) CONSOLE
K103260 · Vasonova, Inc.
OBJ · Catheter, Ultrasound, Intravascular · 106d

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All categories 14795 DXN System, Measurement, Blood-pressure, Non-invasive 925 DQY Catheter, Percutaneous 786 DQX Wire, Guide, Catheter 698 DYB Introducer, Catheter 626 DPS Electrocardiograph 436 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 409 DQO Catheter, Intravascular, Diagnostic 400 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 375 LIT Catheter, Angioplasty, Peripheral, Transluminal 358 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 336 DSI Detector And Alarm, Arrhythmia 306 JOW Sleeve, Limb, Compressible 273 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 268