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
14862 Cardiovascular devices
Cleared
May 09, 2008
PAGEWRITER CARDIOGRAPH
DPS
Electrocardiograph
31d
Cleared
May 09, 2008
WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV
DXN
System, Measurement, Blood-pressure, Non-invasive
106d
Cleared
May 07, 2008
SCOUTPRO CS LEAD INTRODUCER SYSTEM
DQY
Catheter, Percutaneous
30d
Cleared
May 07, 2008
BIO-CONSOLE 560
DWA
Control, Pump Speed, Cardiopulmonary Bypass
44d
Cleared
May 07, 2008
OPTISTAR ELITE INJECTION SYSTEM
DXT
Injector And Syringe, Angiographic
139d
Cleared
May 05, 2008
SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL
DSA
Cable, Transducer And Electrode, Patient, (including Connector)
62d
Cleared
May 05, 2008
CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE
OCL
Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
70d
Cleared
May 02, 2008
ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301
DXT
Injector And Syringe, Angiographic
221d
Cleared
Apr 30, 2008
MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
DRB
Stylet, Catheter
28d
Cleared
Apr 30, 2008
EndoWave Infusion System
QEY
Mechanical Thrombolysis Catheter
77d
Cleared
Apr 29, 2008
FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01
DSA
Cable, Transducer And Electrode, Patient, (including Connector)
55d
Cleared
Apr 28, 2008
FOX PLUS PTA CATHETER
LIT
Catheter, Angioplasty, Peripheral, Transluminal
26d
Cleared
Apr 25, 2008
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039
PNO
Catheter, Percutaneous, Cutting/scoring
94d
Cleared
Apr 25, 2008
PC ECG 1200W SYSTEM
MWI
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
94d
Cleared
Apr 25, 2008
INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5
OGZ
Catheter, Intravascular, Plaque Morphology Evaluation
192d
Cleared
Apr 24, 2008
ZOLL E SERIES DEFIBRILLATOR
MKJ
Automated External Defibrillators (non-wearable)
192d
Cleared
Apr 23, 2008
MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM
DSK
Computer, Blood-pressure
44d
Cleared
Apr 23, 2008
SEDAT MYSHELL LITE
DTL
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
62d
Cleared
Apr 23, 2008
CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02
DRF
Catheter, Electrode Recording, Or Probe, Electrode Recording
68d
Cleared
Apr 23, 2008
AMBULO 2400
DXN
System, Measurement, Blood-pressure, Non-invasive
82d
Cleared
Apr 23, 2008
ZOLL E SERIES 12SL, ANALYSIS OPTION
MKJ
Automated External Defibrillators (non-wearable)
84d
Cleared
Apr 22, 2008
ENDOWAVE INFUSION SYSTEM
KRA
Catheter, Continuous Flush
165d
Cleared
Apr 18, 2008
AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM
DQY
Catheter, Percutaneous
31d
Cleared
Apr 17, 2008
TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
DQX
Wire, Guide, Catheter
20d
Cleared
Apr 17, 2008
CAPIOX SP PUMP (WITH OR WITHOUT X-COATING)
KFM
Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
29d
Looking for a specific cardiovascular device? Search by device name, K-number or manufacturer.
Search all Cardiovascular 510(k) devices