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
14852 Cardiovascular devices
Cleared
Nov 10, 2008
CLUE MEDICAL AND CLUE MEDICAL BASIC
DPS
Electrocardiograph
118d
Cleared
Nov 07, 2008
TELECTRODE WET GEL ECG ELECTRODE
DRX
Electrode, Electrocardiograph
14d
Cleared
Nov 07, 2008
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528
DSI
Detector And Alarm, Arrhythmia
71d
Cleared
Nov 06, 2008
AGILIS NXT STEERABLE INTRODUCER
DYB
Introducer, Catheter
21d
Cleared
Nov 03, 2008
PASSEO-35 PTA CATHETER
DQY
Catheter, Percutaneous
33d
Cleared
Nov 03, 2008
OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER
DQY
Catheter, Percutaneous
53d
Cleared
Oct 31, 2008
MODIFICATION TO CHILLBUSTER PORTABLE ELECTRIC BLANKET , MODEL 8002
DWJ
System, Thermal Regulating
8d
Cleared
Oct 31, 2008
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT
MCW
Catheter, Peripheral, Atherectomy
25d
Cleared
Oct 31, 2008
G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS
DTK
Filter, Intravascular, Cardiovascular
79d
Cleared
Oct 31, 2008
NEURON DELIVERY CATHETER 070
DQY
Catheter, Percutaneous
81d
Cleared
Oct 31, 2008
BP LIMBO XL, BPTANGO XL, BP SALSA XL
DQK
Computer, Diagnostic, Programmable
400d
Cleared
Oct 29, 2008
APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
DTZ
Oxygenator, Cardiopulmonary Bypass
20d
Cleared
Oct 29, 2008
PINNACLE ROII INTRODUCER SHEATH
DYB
Introducer, Catheter
30d
Cleared
Oct 29, 2008
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200).
DXN
System, Measurement, Blood-pressure, Non-invasive
72d
Cleared
Oct 29, 2008
FLOWMEDICA BENEPHIT INFUSION SYSTEMS
KRA
Catheter, Continuous Flush
90d
Cleared
Oct 28, 2008
VTI INTRAOPERATIVE DOPPLER SYSTEMS
DPW
Flowmeter, Blood, Cardiovascular
29d
Cleared
Oct 27, 2008
KING`YIELD WRIST BLOOD PRESSURE MONITOR, MODEL BP201
DXN
System, Measurement, Blood-pressure, Non-invasive
13d
Cleared
Oct 24, 2008
MULLINS-X, MODEL 250X
DQY
Catheter, Percutaneous
25d
Cleared
Oct 23, 2008
EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700
DXZ
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
86d
Cleared
Oct 22, 2008
OMRON MODEL HBP-2070 VITAL SIGNS MONITOR
MWI
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
28d
Cleared
Oct 20, 2008
HYPERQ SYSTEM
MWI
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
46d
Cleared
Oct 20, 2008
DISPOSABLE BLOOD PRESSURE CUFF, MODEL DC100
DXQ
Blood Pressure Cuff
207d
Cleared
Oct 17, 2008
NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT
DXN
System, Measurement, Blood-pressure, Non-invasive
39d
Cleared
Oct 17, 2008
SPIRALFUSE PERIPHERAL INFUSION SYSTEM
QEY
Mechanical Thrombolysis Catheter
74d
Cleared
Oct 17, 2008
MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT
DXZ
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
148d
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