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
Jun 19, 2008
LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRIMARY CONSOLE
DWA
Control, Pump Speed, Cardiopulmonary Bypass
50d
Cleared
Jun 18, 2008
OCCLUSION BALLOON CATHETER, MODEL VENOS
DYG
Catheter, Flow Directed
65d
Cleared
Jun 17, 2008
THREE STAGE VENOUS RETURN CANNULA, MODEL 816460
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
162d
Cleared
Jun 13, 2008
GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
MJN
Catheter, Intravascular Occluding, Temporary
21d
Cleared
Jun 09, 2008
DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES
DXQ
Blood Pressure Cuff
118d
Cleared
Jun 06, 2008
TR-USB TELEPHONIC STETHOSCOPE
DQD
Stethoscope, Electronic
56d
Cleared
Jun 06, 2008
SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100
DWJ
System, Thermal Regulating
158d
Cleared
Jun 04, 2008
FOXCROSS PTA CATHETER
LIT
Catheter, Angioplasty, Peripheral, Transluminal
15d
Cleared
May 30, 2008
AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2
DSB
Plethysmograph, Impedance
49d
Cleared
May 30, 2008
TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT
DWJ
System, Thermal Regulating
73d
Cleared
May 30, 2008
IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM
KFM
Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
532d
Cleared
May 29, 2008
GENESIS ECP
DRN
Device, Counter-pulsating, External
14d
Cleared
May 29, 2008
CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
DSI
Detector And Alarm, Arrhythmia
27d
Cleared
May 28, 2008
MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER
PNO
Catheter, Percutaneous, Cutting/scoring
28d
Cleared
May 28, 2008
DESTINATION RENAL GUIDING SHEATH
DYB
Introducer, Catheter
44d
Cleared
May 28, 2008
UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE
JOW
Sleeve, Limb, Compressible
90d
Cleared
May 28, 2008
NRG TRANSSEPTAL NEEDLE
DXF
Catheter, Septostomy
183d
Cleared
May 21, 2008
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH
DYB
Introducer, Catheter
37d
Cleared
May 19, 2008
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE
DSI
Detector And Alarm, Arrhythmia
315d
Cleared
May 16, 2008
AMPLATZER TORQVUE EXCHANGE SYSTEM
DQY
Catheter, Percutaneous
39d
Cleared
May 14, 2008
REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)
DYB
Introducer, Catheter
1d
Cleared
May 14, 2008
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C
MUD
Oximeter, Tissue Saturation
57d
Cleared
May 14, 2008
HEARTRAK AF
DXH
Transmitters And Receivers, Electrocardiograph, Telephone
387d
Cleared
May 13, 2008
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D
DXN
System, Measurement, Blood-pressure, Non-invasive
95d
Cleared
May 12, 2008
REVOLUTION 45MHZ IVUS IMAGING CATHETER
OBJ
Catheter, Ultrasound, Intravascular
42d
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