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
14989 Cardiovascular devices
Cleared
May 03, 2000
AGILENT INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A AND AGILENT M2/M3/M4 COMPACT PORTABLE PATIENT MONITOR
DSI
Detector And Alarm, Arrhythmia
30d
Cleared
Apr 28, 2000
8100 VITAL SIGNS MONITOR
MWI
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
29d
Cleared
Apr 28, 2000
CORDIS INTRODUCER GUIDE
DQY
Catheter, Percutaneous
18d
Cleared
Apr 28, 2000
POSSIS ANGIOJET X-STREAM RHEOLYTIC THROMBECTOMY CATHETER, MODEL 103587-002
MCW
Catheter, Peripheral, Atherectomy
190d
Cleared
Apr 27, 2000
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
DTM
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
17d
Cleared
Apr 27, 2000
MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
139d
Cleared
Apr 25, 2000
COBE SMARXT OPTIMA XP SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
DTZ
Oxygenator, Cardiopulmonary Bypass
88d
Cleared
Apr 25, 2000
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT HOLLOW FIBRE OXYGENATOR, MODEL D902
DTZ
Oxygenator, Cardiopulmonary Bypass
26d
Cleared
Apr 21, 2000
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS
DQO
Catheter, Intravascular, Diagnostic
28d
Cleared
Apr 19, 2000
LIFECARD CF COMPACT RECORDER
DSH
Recorder, Magnetic Tape, Medical
20d
Cleared
Apr 17, 2000
MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
168d
Cleared
Apr 14, 2000
FIXATION STYLETS, MODELS 335-287 AND 335-288
DRB
Stylet, Catheter
70d
Cleared
Apr 14, 2000
AGILITY STEERABLE GUIDEWIRE
DQX
Wire, Guide, Catheter
14d
Cleared
Apr 13, 2000
CTC DVT-1 CALF GARMENT, MODEL DVT-1
JOW
Sleeve, Limb, Compressible
86d
Cleared
Apr 13, 2000
CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
84d
Cleared
Apr 13, 2000
PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200
DRX
Electrode, Electrocardiograph
83d
Cleared
Apr 13, 2000
BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA
LIT
Catheter, Angioplasty, Peripheral, Transluminal
51d
Cleared
Apr 13, 2000
PERCUTANEOUS INTRODUCER, MODEL 10383-XXX
DYB
Introducer, Catheter
30d
Cleared
Apr 13, 2000
TFX MEDICAL STYLET CATHETER
DRB
Stylet, Catheter
248d
Cleared
Apr 13, 2000
LEMAITRE OCCLUSION CATHETER
MJN
Catheter, Intravascular Occluding, Temporary
226d
Cleared
Apr 13, 2000
DATEX-OHMEDA NE12STPR MODULE (MODEL FAMILY M-NE12STPR)
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
171d
Cleared
Apr 13, 2000
EX 45-BP, MODEL 330 132
DTB
Permanent Pacemaker Electrode
119d
Cleared
Apr 12, 2000
SOFTLINE SPRING CLIP
DXC
Clamp, Vascular
90d
Cleared
Apr 11, 2000
POSSIS ANGIOJET RAPID THOMBECTOMY CATHETERS--F105 CATHETER MODEL 3030C, LF140 CATHETER MODEL 3040C
QEZ
Aspiration Thrombectomy Catheter
1002d
Cleared
Apr 10, 2000
VIRIDIA INFORMATION CENTER SOFTWARE FOR M3150A AND M3153A, VIRIDIA TELEMETRY SYSTEM TRANSMITTER
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
25d
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