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
14832 Cardiovascular devices
5776–5800 of 14832
Cleared Jun 04, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961
K090769 · Andon Health Co, Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 73d
Cleared Jun 04, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909,
K090768 · Andon Health Co, Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 73d
Cleared Jun 04, 2009
MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S
K090114 · Oscor, Inc.
DYB · Introducer, Catheter · 134d
Cleared Jun 04, 2009
OPTION VENA CAVA FILTER
K081410 · Rex Medical
DTK · Filter, Intravascular, Cardiovascular · 380d
Cleared Jun 03, 2009
SE-601 SERIES ELECTROCARDIOGRAPH
K090367 · Edan Instruments, Inc.
DPS · Electrocardiograph · 110d
Cleared Jun 03, 2009
LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL
K083336 · Smiths Medical Asd, Inc.
DWJ · System, Thermal Regulating · 203d
Cleared May 29, 2009
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
K091329 · Terumo Medical Corp.
DYB · Introducer, Catheter · 24d
Cleared May 29, 2009
THE CROSSER 14 OTW CATHETER, MODEL CRU014
K091254 · Flowcardia, Inc.
DQY · Catheter, Percutaneous · 30d
Cleared May 29, 2009
ISOFLOW INFUSION CATHETER
K081147 · Vascular Designs, Inc.
KRA · Catheter, Continuous Flush · 402d
Cleared May 28, 2009
ECSCOPE 100
K091358 · Dyansys, Inc.
DPS · Electrocardiograph · 20d
Cleared May 28, 2009
CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS
K090602 · Cardiodynamics International Corp.
DSB · Plethysmograph, Impedance · 84d
Cleared May 27, 2009
506CN PATIENT MONITOR
K091050 · Criticare Systems, Inc.
DRT · Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · 44d
Cleared May 22, 2009
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19
K090665 · Abbott Vascular-Vascular Solutions
NTE · Temporary Carotid Catheter For Embolic Capture · 70d
Cleared May 22, 2009
MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG
K090037 · Medicalgorithmics SP Z.O.O.
DSI · Detector And Alarm, Arrhythmia · 136d
Cleared May 22, 2009
ENABLER-P CATHETER, 1000 PART NUMBER:1160
K083833 · Endocross, Ltd.
DQY · Catheter, Percutaneous · 150d
Cleared May 22, 2009
ENSITE SYSTEM, MODEL EE3000, AND ENSITE NAVX SURFACE ELECTRODE, MODEL EN0010
K083328 · St Jude Medical
DQK · Computer, Diagnostic, Programmable · 191d
Cleared May 18, 2009
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL
K091206 · Transoma Medical
MXC · Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) · 24d
Cleared May 15, 2009
MODIFICATION TO THE CROSSER SYSTEM
K091119 · Flowcardia, Inc.
PDU · Catheter For Crossing Total Occlusions · 28d
Cleared May 15, 2009
EPICARDIA 5000
K090834 · Medicomp, Inc.
DSI · Detector And Alarm, Arrhythmia · 49d
Cleared May 15, 2009
MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT
K082403 · Gish Biomedical, Inc.
DTZ · Oxygenator, Cardiopulmonary Bypass · 267d
Cleared May 14, 2009
BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER
K081130 · Bridgepoint Medical
DQY · Catheter, Percutaneous · 388d
Cleared May 13, 2009
ST. JUDE MEDICAL EPICARDIAL CATHETER SYSTEM
K081803 · St Jude Medical
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 321d
Cleared May 12, 2009
AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100
K083214 · Aga Medical Corp.
DQY · Catheter, Percutaneous · 193d
Cleared May 08, 2009
ACCUTORR V MONITOR, MODEL 0998-00-2000
K091068 · Datascope Corp., Patient Monitoring Division
DXN · System, Measurement, Blood-pressure, Non-invasive · 24d
Cleared May 08, 2009
ZIO PATCH, MODEL Z100
K090363 · iRhythm Technologies, Inc.
DSH · Recorder, Magnetic Tape, Medical · 84d

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All categories 14832 DXN System, Measurement, Blood-pressure, Non-invasive 930 DQY Catheter, Percutaneous 786 DQX Wire, Guide, Catheter 699 DYB Introducer, Catheter 630 DPS Electrocardiograph 438 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 361 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 336 DSI Detector And Alarm, Arrhythmia 306 JOW Sleeve, Limb, Compressible 276 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 270