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
14811 Cardiovascular devices
Cleared
Dec 30, 2009
BANTAM,48XXXXXX, 50XXXXXX
LIT
Catheter, Angioplasty, Peripheral, Transluminal
86d
Cleared
Dec 30, 2009
ENABLER-P CATHETER SYSTEM, MODEL 3000
DQY
Catheter, Percutaneous
162d
Cleared
Dec 29, 2009
MARS HOLTER ANALYSIS WORKSTATION
DQK
Computer, Diagnostic, Programmable
85d
Cleared
Dec 29, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918
DXN
System, Measurement, Blood-pressure, Non-invasive
127d
Cleared
Dec 24, 2009
PARADIS VASO SHIELD
OMR
Vessel Guard Or Cover
37d
Cleared
Dec 23, 2009
STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO
LIT
Catheter, Angioplasty, Peripheral, Transluminal
21d
Cleared
Dec 23, 2009
STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX
LIT
Catheter, Angioplasty, Peripheral, Transluminal
29d
Cleared
Dec 23, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-571, KD-7971
DXN
System, Measurement, Blood-pressure, Non-invasive
48d
Cleared
Dec 23, 2009
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911
DXN
System, Measurement, Blood-pressure, Non-invasive
128d
Cleared
Dec 23, 2009
ZOLL E SERIES WITH CPRREADYCHARGE
MKJ
Automated External Defibrillators (non-wearable)
237d
Cleared
Dec 23, 2009
VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
DTN
Reservoir, Blood, Cardiopulmonary Bypass
282d
Cleared
Dec 23, 2009
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
DTR
Heat-exchanger, Cardiopulmonary Bypass
296d
Cleared
Dec 23, 2009
VENOUS HARDSHELL CARDIOTOMY RESERVIORS
DTN
Reservoir, Blood, Cardiopulmonary Bypass
299d
Cleared
Dec 18, 2009
AF 840 PH.I.S.I.O. ARTERIAL FILTER
DTM
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
28d
Cleared
Dec 18, 2009
INTELLIBRIDGE SYSTEM
MWI
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
71d
Cleared
Dec 18, 2009
ARROW SELDINGER ARTERIAL CATHERIZATION DEVICES, MODELS EX SAC 00520
DQY
Catheter, Percutaneous
79d
Cleared
Dec 18, 2009
HLM TUBING SET WITH SOFTLINE COATING
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
294d
Cleared
Dec 18, 2009
QUART ARTERIAL FILTER WITH SOFTLINE COATING
DTM
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
295d
Cleared
Dec 18, 2009
ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
KFM
Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
295d
Cleared
Dec 17, 2009
TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE
DQX
Wire, Guide, Catheter
48d
Cleared
Dec 17, 2009
HEALTHEPOD
DXH
Transmitters And Receivers, Electrocardiograph, Telephone
416d
Cleared
Dec 15, 2009
EP -NURSEMATE, EP -NURSEMATE WITH PHYSIO MODULE
DQK
Computer, Diagnostic, Programmable
26d
Cleared
Dec 15, 2009
MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214
MWI
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
267d
Cleared
Dec 14, 2009
ELI 350 ELECTROCARDIOGRAPH
DPS
Electrocardiograph
105d
Cleared
Dec 10, 2009
HOT DOG PATIENT WARMING MATTRESS SYSTEM, MODELS WCUB, M101, M102 AND M103
DWJ
System, Thermal Regulating
90d
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