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
14922 Cardiovascular devices
Cleared
Jan 17, 2006
TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
120d
Cleared
Jan 17, 2006
SUPER SHEATH INTRODUCER SHEATH
DRE
Dilator, Vessel, For Percutaneous Catheterization
123d
Cleared
Jan 13, 2006
MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300,
MCW
Catheter, Peripheral, Atherectomy
31d
Cleared
Jan 13, 2006
SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
OCL
Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue
35d
Cleared
Jan 13, 2006
DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES
DQK
Computer, Diagnostic, Programmable
81d
Cleared
Jan 13, 2006
CARDIOSOFT PC ECG, USB VERSION
DPS
Electrocardiograph
143d
Cleared
Jan 11, 2006
SIMPLICI-T ANNULOPLASTY SYSTEM
KRH
Ring, Annuloplasty
79d
Cleared
Jan 11, 2006
6248VAL ADJUSTABLE VALVE
DTL
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
126d
Cleared
Jan 10, 2006
PHILIPS MP40, MP50, MP60, MP70, MP80 AND MP90 INTELLIVUE PATIENT MONITORS, RELEASE D.00
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
22d
Cleared
Jan 09, 2006
CG-7000DX-BT ECG RECORDER/TRANSMITTER
DXH
Transmitters And Receivers, Electrocardiograph, Telephone
115d
Cleared
Jan 06, 2006
EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN
DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
77d
Cleared
Jan 05, 2006
TANGO+ AUTOMATIC BLOOD PRESSURE AND OXYGEN SATURATION MEASUREMENT SYSTEM
DXN
System, Measurement, Blood-pressure, Non-invasive
50d
Cleared
Jan 05, 2006
KD-768 WRIST MEASUREMENT ELECTRONIC BLOOD PRESSURE MONITOR
DXN
System, Measurement, Blood-pressure, Non-invasive
182d
Cleared
Jan 04, 2006
ECHELON MICRO CATHETER
KRA
Catheter, Continuous Flush
166d
Cleared
Jan 04, 2006
RIO ASPIRATION CATHETER
QEZ
Aspiration Thrombectomy Catheter
177d
Cleared
Jan 03, 2006
POWERHEART ECD
MKJ
Automated External Defibrillators (non-wearable)
131d
Cleared
Jan 03, 2006
TESLAGUARD, MODEL EFT G04
MWI
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
152d
Cleared
Dec 30, 2005
AMPLATZER SIZING BALLOON II
MJN
Catheter, Intravascular Occluding, Temporary
21d
Cleared
Dec 30, 2005
EKOS MICRO-INFUSION SYSTEM
QEY
Mechanical Thrombolysis Catheter
21d
Cleared
Dec 30, 2005
COMMANDER III NON-INVASIVE BLOOD PRESSURE SYSTEM
DXN
System, Measurement, Blood-pressure, Non-invasive
32d
Cleared
Dec 30, 2005
CARDIOCOM COMMANDER III
DXN
System, Measurement, Blood-pressure, Non-invasive
32d
Cleared
Dec 30, 2005
WIRELESS PHYSIOLOGIC MONITORING SYSTEM
DXO
Transducer, Pressure, Catheter Tip
65d
Cleared
Dec 29, 2005
DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3
MSX
System, Network And Communication, Physiological Monitors
66d
Cleared
Dec 27, 2005
FETALGARD LITE-NIBP, MODEL FGL-NIBP
DXN
System, Measurement, Blood-pressure, Non-invasive
167d
Cleared
Dec 23, 2005
BP PRO BLOOD PRESSURE MONITOR
DXN
System, Measurement, Blood-pressure, Non-invasive
17d
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