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
Cleared
Jun 19, 2009
VASCUTEK BRANCHED GELWEAVE
DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
73d
Cleared
Jun 19, 2009
NUVANT CARDIAC EVENT MONITORING SYSTEM
QYX
Outpatient Cardiac Telemetry
95d
Cleared
Jun 19, 2009
FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100
DXT
Injector And Syringe, Angiographic
102d
Cleared
Jun 19, 2009
SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU
DXN
System, Measurement, Blood-pressure, Non-invasive
184d
Cleared
Jun 18, 2009
DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02
DSP
System, Balloon, Intra-aortic And Control
31d
Cleared
Jun 18, 2009
PIGGYBACK WIRE CONVERTER
DQY
Catheter, Percutaneous
73d
Cleared
Jun 18, 2009
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM
DSB
Plethysmograph, Impedance
441d
Cleared
Jun 17, 2009
LUCAS 2
DRM
Compressor, Cardiac, External
119d
Cleared
Jun 17, 2009
TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE
DRX
Electrode, Electrocardiograph
145d
Cleared
Jun 16, 2009
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205
OCL
Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
90d
Cleared
Jun 15, 2009
DDU-2300 SEMIAUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES
MKJ
Automated External Defibrillators (non-wearable)
409d
Cleared
Jun 12, 2009
ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER
DQY
Catheter, Percutaneous
17d
Cleared
Jun 12, 2009
GOPHER GOLD CATHETER, MODEL 5620
DQY
Catheter, Percutaneous
37d
Cleared
Jun 12, 2009
FLOCONTROL , MODEL 1028
MJN
Catheter, Intravascular Occluding, Temporary
67d
Cleared
Jun 12, 2009
QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000
DTZ
Oxygenator, Cardiopulmonary Bypass
106d
Cleared
Jun 10, 2009
COR12+
DSH
Recorder, Magnetic Tape, Medical
20d
Cleared
Jun 08, 2009
CAPIOX BUBBLE TRAP WITH X-COATING
KRL
Detector, Bubble, Cardiopulmonary Bypass
83d
Cleared
Jun 05, 2009
MP5 INTELLIVUE PATIENT MONITOR
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
25d
Cleared
Jun 05, 2009
RADIA STEERABLE DIAGNOSTIC CATHETER
DRF
Catheter, Electrode Recording, Or Probe, Electrode Recording
28d
Cleared
Jun 05, 2009
PLANET 55, MODEL 100
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
105d
Cleared
Jun 05, 2009
STAR 55 MODEL 100
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
133d
Cleared
Jun 05, 2009
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM
DRG
Transmitters And Receivers, Physiological Signal, Radiofrequency
158d
Cleared
Jun 04, 2009
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909
DXN
System, Measurement, Blood-pressure, Non-invasive
73d
Cleared
Jun 04, 2009
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962
DXN
System, Measurement, Blood-pressure, Non-invasive
73d
Cleared
Jun 04, 2009
FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905
DXN
System, Measurement, Blood-pressure, Non-invasive
73d
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