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
14926 Cardiovascular devices
Cleared
Nov 02, 2005
INTELLIVUE PATIENT MONITORS WITH RELEASE C.02, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
30d
Cleared
Nov 02, 2005
DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS
DXT
Injector And Syringe, Angiographic
120d
Cleared
Nov 02, 2005
ASAHI ANGIOGRAPHIC CATHETER
DQO
Catheter, Intravascular, Diagnostic
142d
Cleared
Nov 01, 2005
CARDIOSERVER
DQK
Computer, Diagnostic, Programmable
19d
Cleared
Nov 01, 2005
DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
32d
Cleared
Oct 31, 2005
VP SHEATH
DQY
Catheter, Percutaneous
138d
Cleared
Oct 28, 2005
PHERON PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
LIT
Catheter, Angioplasty, Peripheral, Transluminal
28d
Cleared
Oct 28, 2005
OMRON NON-INVASIVE BLOOD PRESSURE MONITOR WITH AUGMENTATION INDEX, MODEL HEM-9000AI
DXN
System, Measurement, Blood-pressure, Non-invasive
269d
Not Cleared
Oct 28, 2005
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYSTEM AND ENDOSENSOR ELECTRONICS SYSTEM
NQH
Sensor, Pressure, Aneurysm, Implantable
80d
Cleared
Oct 27, 2005
MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX
DQX
Wire, Guide, Catheter
24d
Cleared
Oct 27, 2005
VYGON MICRO-ACCESS SAFETY INTRODUCER KIT
DYB
Introducer, Catheter
164d
Cleared
Oct 25, 2005
PERIPRO PATCH
DXZ
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
53d
Cleared
Oct 21, 2005
POWERHEART AED G3 (MODEL 9390E), POWERHEART AED G3 AUTOMATIC (MODEL 9390A)
MKJ
Automated External Defibrillators (non-wearable)
73d
Cleared
Oct 20, 2005
D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER
DTM
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
21d
Cleared
Oct 20, 2005
M3046B COMPACT PORTABLE PATIENT MONITORS
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
21d
Cleared
Oct 19, 2005
CLIRPATH TURBO PLUS EXCIMER LASER CATHETERS, MODELS 314-151, 314-159, 317-152, 317-156, 320-006, 320-159, 323-001
PDU
Catheter For Crossing Total Occlusions
35d
Cleared
Oct 19, 2005
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002
QYX
Outpatient Cardiac Telemetry
63d
Cleared
Oct 19, 2005
BLOOD PRESSURE METER, MODEL CH-432
DXN
System, Measurement, Blood-pressure, Non-invasive
82d
Cleared
Oct 17, 2005
DUAL SHOT - CONTRAST DELIVERY SYSTEM
DXT
Injector And Syringe, Angiographic
21d
Cleared
Oct 13, 2005
KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE
JOW
Sleeve, Limb, Compressible
100d
Cleared
Oct 07, 2005
VITALCAREGIVING SYSTEM
DXH
Transmitters And Receivers, Electrocardiograph, Telephone
119d
Cleared
Oct 05, 2005
PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A
MKJ
Automated External Defibrillators (non-wearable)
107d
Cleared
Oct 05, 2005
CARDIOLINE AR 600, AR 1200, AR 2100
DPS
Electrocardiograph
117d
Cleared
Sep 30, 2005
TECHNO-SCOPE VISUAL STETHOSCOPE
DQD
Stethoscope, Electronic
259d
Cleared
Sep 29, 2005
NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER
DRF
Catheter, Electrode Recording, Or Probe, Electrode Recording
58d
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