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.
18151
Total
18097
Cleared
152d
Avg (2y)
1976
Since
15055 Cardiovascular devices
Cleared
Jan 17, 1996
LIFE-AIR 1000 HYPOTHERMIC THERAPY SYSTEM
DWJ
System, Thermal Regulating
244d
Cleared
Jan 16, 1996
LIFESIGNS RECEIVING CENER 2000 TRANSTELEPHONIC RECEIVER
DXH
Transmitters And Receivers, Electrocardiograph, Telephone
315d
Cleared
Jan 16, 1996
PACEART CARDIOVOICE
DXH
Transmitters And Receivers, Electrocardiograph, Telephone
259d
Cleared
Jan 16, 1996
SCIMED ANGIOGRAPHIC KITS
DQY
Catheter, Percutaneous
187d
Cleared
Jan 16, 1996
BIOTREND OXYGEN SATURATION & HEMATOCRIT SYSTEM
DTY
Sensor, Blood-gas, In-line, Cardiopulmonary Bypass
110d
Cleared
Jan 11, 1996
TRONOMATE PATIENT CABLE & LEADWIRE SYSTEM
DSA
Cable, Transducer And Electrode, Patient, (including Connector)
213d
Cleared
Jan 11, 1996
PEDIATRIC QUIK-COMBO
MKJ
Automated External Defibrillators (non-wearable)
189d
Cleared
Jan 11, 1996
PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS
DSP
System, Balloon, Intra-aortic And Control
108d
Cleared
Jan 11, 1996
SOFT VENOUS RESERVOIR
DTN
Reservoir, Blood, Cardiopulmonary Bypass
69d
Cleared
Jan 04, 1996
HOLTER 6000
DQK
Computer, Diagnostic, Programmable
307d
Cleared
Jan 04, 1996
HEWLETT-PACKARD MODEL M1791A ACUTE CARDIAC ISCHEMIA-TIME INSENSITIVE PREDICITIVE INSTRUMENT (ACI-TIPT)
LOS
252d
Cleared
Jan 04, 1996
HEARTSTART 911
MKJ
Automated External Defibrillators (non-wearable)
92d
Cleared
Jan 02, 1996
MICRO THERAPEUTICS SIDEHOLE INFUSION WIRE
KRA
Catheter, Continuous Flush
158d
Cleared
Dec 29, 1995
ZOLL PD2000 PACEMAKER/ADVISORY DEFIBRILLATOR, MODEL PD2000, ZOLL D2000 ADVISORY DEFIBRILLATOR, MODEL D2000
DRO
Pacemaker, Cardiac, External Transcutaneous (non-invasive)
305d
Cleared
Dec 29, 1995
LIFEPAK 11
DRO
Pacemaker, Cardiac, External Transcutaneous (non-invasive)
267d
Cleared
Dec 28, 1995
DIGITAL ELECTRONIC WRIST BLOOD PRESSURE MONITOR
DXN
System, Measurement, Blood-pressure, Non-invasive
212d
Cleared
Dec 28, 1995
CORDIS BRITE TIP SHEATH INTRODUCER
DYB
Introducer, Catheter
86d
Cleared
Dec 26, 1995
TRANSPORT CART
DSP
System, Balloon, Intra-aortic And Control
204d
Cleared
Dec 22, 1995
GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS
DQX
Wire, Guide, Catheter
499d
Cleared
Dec 22, 1995
Multi Side Hole lnfusion System
QEY
Mechanical Thrombolysis Catheter
156d
Cleared
Dec 22, 1995
TRANSIT INFUSION CATHETER WITH SIDEHOLES
KRA
Catheter, Continuous Flush
53d
Cleared
Dec 20, 1995
COURIER BALLOON DILATATION CATHETER
LIT
Catheter, Angioplasty, Peripheral, Transluminal
142d
Cleared
Dec 20, 1995
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
LIT
Catheter, Angioplasty, Peripheral, Transluminal
140d
Cleared
Dec 19, 1995
VASCUTEK GELWEAVE VASCULAR GRAFT
DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
217d
Cleared
Dec 15, 1995
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
DXY
Implantable Pacemaker Pulse-generator
127d
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