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
14951 Cardiovascular devices
Cleared
May 17, 2004
LAKE REGION HYDROPHILIC GUIDEWIRE
DQX
Wire, Guide, Catheter
48d
Cleared
May 17, 2004
MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200
DXN
System, Measurement, Blood-pressure, Non-invasive
7d
Cleared
May 14, 2004
INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
144d
Cleared
May 12, 2004
REFLEXION CANNULATOR STEERABLE ELECTROPHYSIOLOGY CATHETER WITH LUMEN, MODEL 402805
DRA
Catheter, Steerable
107d
Cleared
May 12, 2004
MODIFICATION TO INFINITY EXPLORER
MSX
System, Network And Communication, Physiological Monitors
30d
Cleared
May 12, 2004
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.01 AND INTELLIVUE CLINICAL NETWORK ON VLAN
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
29d
Cleared
May 12, 2004
INFINITY GAMMA
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
16d
Cleared
May 06, 2004
INTRA-AORTIC BALLOON (IAB)
DSP
System, Balloon, Intra-aortic And Control
38d
Cleared
May 06, 2004
D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS
DTM
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
13d
Cleared
May 06, 2004
NUMED MULLINS X PTA CATHETER
DQY
Catheter, Percutaneous
9d
Cleared
May 05, 2004
GORE TRI-LOBE BALLOON CATHETER
DQY
Catheter, Percutaneous
163d
Cleared
May 04, 2004
HEARTSTART MRX, MODEL M3535A
MKJ
Automated External Defibrillators (non-wearable)
77d
Cleared
Apr 30, 2004
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
DQX
Wire, Guide, Catheter
28d
Cleared
Apr 29, 2004
ATLANTIS SR, MODEL C4020
DQO
Catheter, Intravascular, Diagnostic
34d
Cleared
Apr 27, 2004
CLIRPATH EXCIMER LASER CATHETER
PDU
Catheter For Crossing Total Occlusions
104d
Cleared
Apr 27, 2004
SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000
DWJ
System, Thermal Regulating
48d
Cleared
Apr 26, 2004
VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR
DXG
Computer, Diagnostic, Pre-programmed, Single-function
80d
Cleared
Apr 19, 2004
VASCUPUNCTURE PICC GUIDEWIRE WITH HYDRO-SILK COATING
DQX
Wire, Guide, Catheter
21d
Cleared
Apr 14, 2004
CARDIOVIT AT-102
DPS
Electrocardiograph
331d
Cleared
Apr 13, 2004
INTERLOCKING DETACHABLE COIL SYSTEM (IDC)
KRD
Device, Vascular, For Promoting Embolization
61d
Cleared
Apr 09, 2004
AVITA BPM6 SERIES BLOOD PRESSURE METER (OR MONITOR), MODEL BPM6XY
DXN
System, Measurement, Blood-pressure, Non-invasive
168d
Cleared
Apr 09, 2004
BIO-DETEK ELECTRODE ADAPTER, MODEL R2001-90
MKJ
Automated External Defibrillators (non-wearable)
87d
Cleared
Apr 09, 2004
PEDI-PADZ RADIOLUCENT MULTI-FUNCTION PEDIATRIC ELECTRODES, MODEL 8900-1005
MKJ
Automated External Defibrillators (non-wearable)
65d
Cleared
Apr 07, 2004
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU
DTB
Permanent Pacemaker Electrode
34d
Cleared
Apr 07, 2004
PROTAB ECG TABB ELECTRODE
DRX
Electrode, Electrocardiograph
9d
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