FDA Review Panel · CV

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
14985 Cardiovascular devices
8426–8450 of 14985
Cleared Aug 16, 2000
GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300
K001969 · Medtronic Vascular
DQY · Catheter, Percutaneous · 49d
Cleared Aug 16, 2000
SLIMCATH-DX MODELS, 3SUXXXX, 3SBXXXX, AND FCXXXX
K993698 · Mogul Enterprises
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 288d
Cleared Aug 15, 2000
V QUICK PATCH
K993934 · Vq Corp.
DRX · Electrode, Electrocardiograph · 271d
Cleared Aug 11, 2000
BMT ANSCORE HEALTH MANAGEMENT SYSTEM
K993875 · Boston Medical Technologies, Inc.
DPS · Electrocardiograph · 270d
Cleared Aug 10, 2000
CARDIOSET (HARDWARE), MODEL HO4
K001091 · Next Millennium Software Solutions, Inc.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 128d
Cleared Aug 10, 2000
STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB
K001565 · Edwards Lifesciences, LLC
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 83d
Cleared Aug 09, 2000
QUINTON Q-STRESS, MODEL 000483
K001492 · Quinton, Inc.
DPS · Electrocardiograph · 89d
Cleared Aug 09, 2000
TRUE
K993913 · Infinity Extrusion & Engineering, Inc.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 266d
Cleared Aug 04, 2000
R.TEST EVOLUTION
K993788 · Novacor Div.
MLO · Electrocardiograph, Ambulatory, With Analysis Algorithm · 269d
Cleared Aug 03, 2000
MIRAGE HYDROPHILIC GUIDEWIRE, MODEL 103-0608
K002212 · Micro Therapeutics, Inc.
DQX · Wire, Guide, Catheter · 13d
Cleared Aug 03, 2000
EXCELSIOR 1018 MICROCATHETER
K994155 · Boston Scientific, Target
KRA · Catheter, Continuous Flush · 238d
Cleared Aug 02, 2000
CHASE CARDIOVASCULAR PATCH
K001662 · Chase Medical, Inc.
DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · 63d
Cleared Aug 02, 2000
GALEO HYDRO AND GALEO HYDRO J-TIP
K001736 · Biotronik, Inc.
DQX · Wire, Guide, Catheter · 56d
Cleared Aug 02, 2000
HP M2376A DEVICE LINK SYSTEM, MODEL M2376A
K002009 · Agilent Technologies, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 30d
Cleared Aug 01, 2000
COAXIAL DILATOR SET
K000737 · Xentek Medical, Inc.
DRE · Dilator, Vessel, For Percutaneous Catheterization · 147d
Cleared Aug 01, 2000
MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP-3BU1
K001182 · Microlife Corp.
DXN · System, Measurement, Blood-pressure, Non-invasive · 112d
Cleared Jul 25, 2000
A&D MEDICAL LIFESOURCE UB-401PC & UB-401 DIGITAL BLOOD PRESSURE MONITORS
K002115 · A&D Engineering, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 12d
Cleared Jul 21, 2000
BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES
K001390 · Biosense Webster, Inc.
DSA · Cable, Transducer And Electrode, Patient, (including Connector) · 80d
Cleared Jul 21, 2000
CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510
K994141 · Medtronic Ave, Inc.
MJN · Catheter, Intravascular Occluding, Temporary · 226d
Cleared Jul 20, 2000
PTA BALLOON CATHETER
K001087 · Cook, Inc.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 107d
Cleared Jul 20, 2000
REBAR MICRO CATHETER: REBAR-18 [2.3F], 110 CM, 130 CM, 153 CM, SINGLE MARKER BAND AND 153 CM, DUAL MARKER BAND
K001966 · Micro Therapeutics, Inc.
KRA · Catheter, Continuous Flush · 22d
Cleared Jul 20, 2000
BOOKER BOX, MODEL PAD 5010
K993205 · Tz Medical, Inc.
LDD · Dc-defibrillator, Low-energy, (including Paddles) · 300d
Cleared Jul 18, 2000
DASH 3000/4000 PATIENT MONITOR
K001359 · General Electric Medical Systems Information Techn
DSI · Detector And Alarm, Arrhythmia · 81d
Cleared Jul 17, 2000
GE MARQUETTE PRISM INFORMATION SERVER APPLICATIONS
K001268 · General Electric Medical Systems Information Techn
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 88d
Cleared Jul 13, 2000
DATEX-OHMEDA NETWORK AND CENTRAL
K000647 · Datex-Ohmeda, Inc.
MSX · System, Network And Communication, Physiological Monitors · 136d

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All categories 14985 DXN System, Measurement, Blood-pressure, Non-invasive 942 DQY Catheter, Percutaneous 792 DQX Wire, Guide, Catheter 702 DYB Introducer, Catheter 638 DPS Electrocardiograph 444 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 413 DQO Catheter, Intravascular, Diagnostic 404 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 377 LIT Catheter, Angioplasty, Peripheral, Transluminal 366 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 339 DSI Detector And Alarm, Arrhythmia 310 JOW Sleeve, Limb, Compressible 288 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 275