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
14994 Cardiovascular devices
Cleared
Jan 04, 2000
INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE
DYB
Introducer, Catheter
18d
Cleared
Dec 29, 1999
SULZER CARBOMEDICS CARDIOFIX PERICARDIUM
DXZ
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
89d
Cleared
Dec 29, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL V46
DXN
System, Measurement, Blood-pressure, Non-invasive
71d
Cleared
Dec 28, 1999
A-MED VASCULAR CANNULA, MODELS V24-10-08, V24-10-16, V24-10-32, V24-21-08, V24-21-44
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
239d
Cleared
Dec 28, 1999
NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100
MWJ
Electrocardiograph, Ambulatory (without Analysis)
61d
Cleared
Dec 21, 1999
PATHFINDER II ANGIOGRAPHIC CATHETER
DQO
Catheter, Intravascular, Diagnostic
336d
Cleared
Dec 21, 1999
CG-2100 ECG TRANSMITTER
DXH
Transmitters And Receivers, Electrocardiograph, Telephone
25d
Cleared
Dec 20, 1999
EMBOLIZATION COIL SYSTEM
KRD
Device, Vascular, For Promoting Embolization
180d
Cleared
Dec 20, 1999
INTERFACE MODULE IDDD
KRI
Accessory Equipment, Cardiopulmonary Bypass
136d
Cleared
Dec 20, 1999
MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
DRG
Transmitters And Receivers, Physiological Signal, Radiofrequency
89d
Cleared
Dec 20, 1999
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z46
DXN
System, Measurement, Blood-pressure, Non-invasive
69d
Cleared
Dec 20, 1999
A & D MEDICALLIFESOURCE US-779PC & UA-779T DIGITAL BLOOD PRESSURE MONITORS
DXN
System, Measurement, Blood-pressure, Non-invasive
34d
Cleared
Dec 17, 1999
YP 45/15-BP
DTB
Permanent Pacemaker Electrode
88d
Cleared
Dec 15, 1999
QMS MAPPING SYSTEM,MODEL 2000
DQK
Computer, Diagnostic, Programmable
342d
Cleared
Dec 12, 1999
INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS MONITOR
DSK
Computer, Blood-pressure
452d
Cleared
Dec 10, 1999
DRG CONVENTIONAL ELECTRONIC DIGITAL STETHOSCOPE, MODEL ECHOP 200-00
DQD
Stethoscope, Electronic
204d
Cleared
Dec 10, 1999
3 CHANNEL KNEE ELECTRONIC AMPLIFIED STETHOSCOPE
DQD
Stethoscope, Electronic
200d
Cleared
Dec 10, 1999
LUMA-CATH STEERABLE EP CATHETERS
DRF
Catheter, Electrode Recording, Or Probe, Electrode Recording
191d
Cleared
Dec 10, 1999
CHEST DRAINAGE TUBING
DWE
Tubing, Pump, Cardiopulmonary Bypass
88d
Cleared
Dec 10, 1999
SURVIVALINK MULTIFUNCTIONAL ELECTRODE (SVL-9630)
MKJ
Automated External Defibrillators (non-wearable)
87d
Cleared
Dec 10, 1999
CG-7000DX ECG RECORDER/TRANSMITTER
DXH
Transmitters And Receivers, Electrocardiograph, Telephone
31d
Cleared
Dec 09, 1999
SULZER VASCUTEK GELSOFT VASCULAR PROSTHESIS
DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
295d
Cleared
Dec 09, 1999
LEMAITRE EMBOLECTOMY CATHETER
DXE
Catheter, Embolectomy
147d
Cleared
Dec 08, 1999
HP VIRIDIA COMPONENT MONITORING SYSTEM, MODEL REV. K WITH EASI-ST SEGMENT MEASUREMENT, HP VIRIDIA CMS 24/26, REV K WITH
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
127d
Cleared
Dec 07, 1999
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH
DXT
Injector And Syringe, Angiographic
29d
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