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
14985 Cardiovascular devices
Cleared
Jun 09, 2000
UEDA UDEX SUPER BP-2000 AUTOMATIC BLOOD PRESSURE RECORDING DEVICE
DXN
System, Measurement, Blood-pressure, Non-invasive
249d
Cleared
Jun 08, 2000
TALON BALLOON DILATION CATHETER
LIT
Catheter, Angioplasty, Peripheral, Transluminal
87d
Cleared
Jun 08, 2000
AS/3 ANESTHESIA MONTIOR WITH S-ANE99(A)/L-ARK99(A)
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
87d
Cleared
Jun 08, 2000
DIDECO LILLIPUT 1 TWIN RESERVOIR WITH PHOSPHORILCHOLINE INSERT SURFACE IN OXYGENATION (PH. I.S.I.O.)
DTN
Reservoir, Blood, Cardiopulmonary Bypass
15d
Cleared
Jun 08, 2000
ENGUARD PHX CARDIOPLEGIA HEAT EXCHANGER
DTR
Heat-exchanger, Cardiopulmonary Bypass
430d
Cleared
Jun 08, 2000
ENGAGE JAW INSERTS
DXC
Clamp, Vascular
279d
Cleared
Jun 07, 2000
AGILENT M2636A TELEMON MONITOR
DSI
Detector And Alarm, Arrhythmia
30d
Cleared
Jun 07, 2000
SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 DIAMETER, 145CM LENGTH, SUPPORT) SILVERSPEED HYDROPHILIC GUIDEWIRE (0.014 D
DQX
Wire, Guide, Catheter
29d
Cleared
Jun 07, 2000
CIPA (ADULTS) CIPI (INFANTS)
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
281d
Cleared
Jun 05, 2000
AVANAR F/X 2.9F INTRAVASCULAR ULTRASOUND IMAGING CATHETER, MODEL 85700
DQO
Catheter, Intravascular, Diagnostic
84d
Cleared
Jun 05, 2000
DATEX-OHMEDA CS/3 TELEMETRY SYSTEM
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
77d
Cleared
Jun 05, 2000
X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR
DTZ
Oxygenator, Cardiopulmonary Bypass
210d
Cleared
Jun 02, 2000
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668
DTB
Permanent Pacemaker Electrode
29d
Cleared
Jun 02, 2000
VIKING OPTIMA GUIDING CATHETER
DQY
Catheter, Percutaneous
25d
Cleared
May 31, 2000
FAST-CATH 18F HEMOSTASIS INTRODUCER, MODEL 406XXX
DYB
Introducer, Catheter
30d
Cleared
May 31, 2000
ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART B
DXT
Injector And Syringe, Angiographic
553d
Cleared
May 31, 2000
MODIFICATION TO ACIST CL 100H
DXT
Injector And Syringe, Angiographic
426d
Cleared
May 26, 2000
DINAMAP ADVANCED NIBP MODULE
DXN
System, Measurement, Blood-pressure, Non-invasive
102d
Cleared
May 26, 2000
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (REVAS)
DYB
Introducer, Catheter
291d
Cleared
May 24, 2000
GE MARQUETTE MEDICAL SYSTEMS PRUCKA CARDIOLAB CATH SYSTEM, VERSION 1.11
DPS
Electrocardiograph
89d
Cleared
May 24, 2000
ULTIMUM HEMOSTASIS INTRODUCER, MODEL 4076XX
DYB
Introducer, Catheter
26d
Cleared
May 23, 2000
CARDTEL, MODEL NT-100
MWJ
Electrocardiograph, Ambulatory (without Analysis)
90d
Cleared
May 19, 2000
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
DSP
System, Balloon, Intra-aortic And Control
74d
Cleared
May 19, 2000
PROAIR 3000 COMPRESSION SYSTEM
JOW
Sleeve, Limb, Compressible
196d
Cleared
May 18, 2000
APEXPRO TELEMETRY SYSTEM
DSI
Detector And Alarm, Arrhythmia
69d
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