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
14956 Cardiovascular devices
Cleared
Jan 16, 2003
KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR
DXQ
Blood Pressure Cuff
101d
Cleared
Jan 16, 2003
SKINTACT
DRX
Electrode, Electrocardiograph
52d
Cleared
Jan 16, 2003
SKINTACT ECG ELECTRODES WITH KL 02 LIQUID GEL
DRX
Electrode, Electrocardiograph
24d
Cleared
Jan 15, 2003
STEREOTAXIS NIOBE MAGNETIC NAVIGATION SYSTEM
DXX
System, Catheter Control, Steerable
247d
Cleared
Jan 15, 2003
TM2005 PERSONAL MEDICAL PHONE CENTER
DXH
Transmitters And Receivers, Electrocardiograph, Telephone
15d
Cleared
Jan 14, 2003
OVER THE WIRE EMBOLECTOMY CATHETER, MODEL 2302
DXE
Catheter, Embolectomy
196d
Cleared
Jan 14, 2003
HL888
DXN
System, Measurement, Blood-pressure, Non-invasive
57d
Cleared
Jan 14, 2003
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT
DQO
Catheter, Intravascular, Diagnostic
29d
Cleared
Jan 14, 2003
PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR
DTD
Pacemaker Lead Adaptor
28d
Cleared
Jan 10, 2003
MEDRAD STELLANT CT INJECTOR SYSTEM
DXT
Injector And Syringe, Angiographic
108d
Cleared
Jan 09, 2003
CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM
DQK
Computer, Diagnostic, Programmable
297d
Cleared
Jan 08, 2003
ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
29d
Cleared
Dec 31, 2002
BMC CATHETER CONNECTOR CABLE, MODEL RFP-101
DSA
Cable, Transducer And Electrode, Patient, (including Connector)
85d
Cleared
Dec 30, 2002
ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY
DQY
Catheter, Percutaneous
24d
Cleared
Dec 30, 2002
ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY
DQY
Catheter, Percutaneous
24d
Cleared
Dec 24, 2002
FEMOSTOP FEMORAL COMPRESSION SYSTEM
DXC
Clamp, Vascular
11d
Cleared
Dec 18, 2002
SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
5d
Cleared
Dec 12, 2002
OMRON AUTOMATIC BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODELS HEM-773, HEM-773AC
DXN
System, Measurement, Blood-pressure, Non-invasive
204d
Cleared
Dec 12, 2002
VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS
NLH
Catheter, Recording, Electrode, Reprocessed
79d
Cleared
Dec 11, 2002
KSEA DEPLOYABLE CARDIOVASCULAR CLAMP
DXC
Clamp, Vascular
349d
Cleared
Dec 11, 2002
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS
DTB
Permanent Pacemaker Electrode
27d
Cleared
Dec 11, 2002
CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
20d
Cleared
Dec 10, 2002
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
DQY
Catheter, Percutaneous
67d
Cleared
Dec 04, 2002
M3046A (M2/M3/M4) COMPACT PORTABLE PATIENT MONITOR AND MP60 & MP70 INTELLIVUE PATIENT MONITOR WITH PORTAL TECHNOLOGY
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
14d
Cleared
Dec 03, 2002
NEWCOR
DQK
Computer, Diagnostic, Programmable
295d
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