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
14917 Cardiovascular devices
Cleared
Jun 07, 2006
BRIVANT GUIDEWIRE
DQX
Wire, Guide, Catheter
97d
Cleared
Jun 06, 2006
STOCKERT HEATER-COOLER SYSTEM 3T
DWC
Controller, Temperature, Cardiopulmonary Bypass
258d
Cleared
Jun 02, 2006
SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX
DQX
Wire, Guide, Catheter
36d
Cleared
Jun 02, 2006
D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W
DTZ
Oxygenator, Cardiopulmonary Bypass
49d
Cleared
Jun 02, 2006
STOCKERT S5 SYSTEM
DTQ
Console, Heart-lung Machine, Cardiopulmonary Bypass
147d
Cleared
May 30, 2006
HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE
DQX
Wire, Guide, Catheter
98d
Cleared
May 26, 2006
THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
39d
Cleared
May 24, 2006
CARDIOFAX CE, MODEL ECG-1500 A
DPS
Electrocardiograph
252d
Cleared
May 23, 2006
CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R
KRH
Ring, Annuloplasty
29d
Cleared
May 23, 2006
DVTCARE CA5
JOW
Sleeve, Limb, Compressible
29d
Cleared
May 23, 2006
ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32
KFM
Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
36d
Cleared
May 19, 2006
ARGUS, MODEL LCM
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
184d
Cleared
May 18, 2006
ENPATH MEDICAL STEERABLE SHEATH
DQY
Catheter, Percutaneous
27d
Cleared
May 18, 2006
MODIFICATION TO: SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS P4028/FG08300
MCW
Catheter, Peripheral, Atherectomy
31d
Cleared
May 18, 2006
PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS
MWI
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
184d
Cleared
May 17, 2006
SURETEK MEDICAL REPROCESSED COMPRESSION SLEEVES
JOW
Sleeve, Limb, Compressible
231d
Cleared
May 15, 2006
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
17d
Cleared
May 15, 2006
MODIFICATION TO POWERHEART ECD
MKJ
Automated External Defibrillators (non-wearable)
40d
Cleared
May 15, 2006
MODIFICATION TO: CARDIMA ABLATION SYSTEM
OCL
Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
59d
Cleared
May 15, 2006
MORTARA SURVEYOR TELEMETRY CENTRAL STATION
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
116d
Cleared
May 12, 2006
IVENA VASCULAR PATCH
DXZ
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
86d
Cleared
May 12, 2006
MICRUS COURIER MICROCATHETERS
DQO
Catheter, Intravascular, Diagnostic
115d
Cleared
May 10, 2006
EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0
DRE
Dilator, Vessel, For Percutaneous Catheterization
29d
Cleared
May 10, 2006
ESTECH AORTIC EASY FLOW CANNULA
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
118d
Cleared
May 09, 2006
ACON AUTOMATIC BLOOD PRESSURE MONITOR KIT, MODEL OB11-111, W/AC ADAPTER, MODEL OB11-112
DXN
System, Measurement, Blood-pressure, Non-invasive
35d
Looking for a specific cardiovascular device? Search by device name, K-number or manufacturer.
Search all Cardiovascular 510(k) devices