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
14943 Cardiovascular devices
Cleared
Jan 06, 2005
READMYHEART
DPS
Electrocardiograph
86d
Cleared
Jan 06, 2005
CARDIOFAX CE, MODEL PEA-1110K
DPS
Electrocardiograph
86d
Cleared
Jan 06, 2005
MODIFICATION TO PM-8000 PATIENT MONITOR
MWI
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
31d
Cleared
Jan 05, 2005
VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES
DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
9d
Cleared
Dec 28, 2004
CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508
DQY
Catheter, Percutaneous
118d
Cleared
Dec 23, 2004
DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
27d
Cleared
Dec 22, 2004
Lysus Infusion System
QEY
Mechanical Thrombolysis Catheter
26d
Cleared
Dec 17, 2004
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
DQX
Wire, Guide, Catheter
284d
Cleared
Dec 17, 2004
TORAYGUIDE GUIDEWIRE
DQX
Wire, Guide, Catheter
108d
Cleared
Dec 17, 2004
MODIFICATION TO SHORT INTRODUCER SHEATH
DYB
Introducer, Catheter
105d
Cleared
Dec 17, 2004
SJM RIGID SADDLE RING MODEL RSAR-(SIZE)
KRH
Ring, Annuloplasty
77d
Cleared
Dec 13, 2004
6F Z4 GUIDE CATHETER
DQY
Catheter, Percutaneous
90d
Cleared
Dec 10, 2004
MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM
DXT
Injector And Syringe, Angiographic
65d
Cleared
Dec 09, 2004
ACS MODEL NCP-2
DRN
Device, Counter-pulsating, External
93d
Cleared
Dec 09, 2004
VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2
DXG
Computer, Diagnostic, Pre-programmed, Single-function
30d
Cleared
Dec 08, 2004
BIOZDX HEMODYNAMIC MONITOR
DSB
Plethysmograph, Impedance
208d
Cleared
Dec 06, 2004
H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM
DXN
System, Measurement, Blood-pressure, Non-invasive
19d
Cleared
Dec 03, 2004
HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES
DQK
Computer, Diagnostic, Programmable
116d
Cleared
Dec 03, 2004
A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512
DXN
System, Measurement, Blood-pressure, Non-invasive
36d
Cleared
Dec 03, 2004
PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49
MJN
Catheter, Intravascular Occluding, Temporary
30d
Cleared
Dec 02, 2004
WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES
DXN
System, Measurement, Blood-pressure, Non-invasive
163d
Cleared
Nov 30, 2004
ENPATH SAFETY INTRODUCER
DYB
Introducer, Catheter
160d
Cleared
Nov 30, 2004
OPTIV ANTAGE DH POWER INJECTION SYSTEM
DXT
Injector And Syringe, Angiographic
57d
Cleared
Nov 24, 2004
GUIDEWIRES
DQX
Wire, Guide, Catheter
93d
Cleared
Nov 24, 2004
COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE
DQX
Wire, Guide, Catheter
23d
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