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.

18110
Total
18057
Cleared
149d
Avg (2y)
1976
Since
14968 Cardiovascular devices
8226–8250 of 14968
Cleared Jun 21, 2001
6F MACH 1, MODEL 34356-XXX
K010874 · Boston Scientific Corp
DQY · Catheter, Percutaneous · 90d
Cleared Jun 20, 2001
HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4470, 104-4471, 104-4770, 104-4771
K011656 · Micro Therapeutics, Inc.
MJN · Catheter, Intravascular Occluding, Temporary · 22d
Cleared Jun 18, 2001
RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET
K010974 · Sorin Group Italia S.R.L.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 77d
Cleared Jun 15, 2001
CORDIS M3 PTA DILATATION CATHETER
K003920 · Cordis Corp.
DQY · Catheter, Percutaneous · 178d
Cleared Jun 15, 2001
CRYOCARE CARDIAC SURGICAL SYSTEM
K011040 · Endocare, Inc.
OCL · Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue · 71d
Cleared Jun 14, 2001
PORTABLE INSTENSIVE CARE UNIT
K010207 · Medical Research Laboratories, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 142d
Cleared Jun 14, 2001
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL BPW138
K011523 · Rossmax International , Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 28d
Cleared Jun 14, 2001
HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4118, 104-4121, 104-4129, 104-4126, 104-4115, 104-4123
K011526 · Micro Therapeutics, Inc.
MJN · Catheter, Intravascular Occluding, Temporary · 28d
Cleared Jun 13, 2001
AVIATOR PERIPHERAL DILATATION CATHETER
K010831 · Guidant Corp.
DQY · Catheter, Percutaneous · 85d
Cleared Jun 11, 2001
H-SCRIBE
K004017 · Mortara Instrument, Inc.
MLO · Electrocardiograph, Ambulatory, With Analysis Algorithm · 166d
Cleared Jun 11, 2001
HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B
K010634 · Agilent Technologies, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 101d
Cleared Jun 08, 2001
WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM
K010186 · Welch Allyn, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 137d
Cleared Jun 08, 2001
M2376A DEVICELINK SYSTEM, MODEL M2376A
K011578 · Agilent Technologies, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 17d
Cleared Jun 06, 2001
TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A
K010083 · Cordis Corp.
DTK · Filter, Intravascular, Cardiovascular · 146d
Cleared May 31, 2001
INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX
K002847 · Maxxim Medical
DYB · Introducer, Catheter · 260d
Cleared May 23, 2001
CAMBRIDGE HEART MODEL CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K011324 · Cambridge Heart, Inc.
DQK · Computer, Diagnostic, Programmable · 22d
Cleared May 22, 2001
CONCENTRIC RETRIEVER, MODEL 90030
K003410 · Concentric Medical, Inc.
DQY · Catheter, Percutaneous · 201d
Cleared May 22, 2001
OSCOR PERMANENT PACING LEAD RZ MODEL SERIES
K003918 · Oscor, Inc.
DTB · Permanent Pacemaker Electrode · 154d
Cleared May 22, 2001
PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS
K010787 · Oscor, Inc.
DTD · Pacemaker Lead Adaptor · 68d
Cleared May 18, 2001
VASO PRESS DVT FOOT GARMENT #VP 520
K003828 · Britt Corp., Inc.
JOW · Sleeve, Limb, Compressible · 158d
Cleared May 18, 2001
EQUINOX OCCULSION BALLOON SYSTEM MODEL # 104-4015, 104-4018, 104-4021, 104-4023, 104-4026
K010162 · Micro Therapeutics, Inc.
MJN · Catheter, Intravascular Occluding, Temporary · 121d
Cleared May 18, 2001
ADVANTA SST GRAFT (>_6MM)
K010516 · Atrium Medical Corp.
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 85d
Cleared May 18, 2001
ADVANTA SST GRAFT (<6MM)
K010517 · Atrium Medical Corp.
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 85d
Cleared May 16, 2001
CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012
K003084 · Concentric Medical, Inc.
DQX · Wire, Guide, Catheter · 225d
Cleared May 16, 2001
CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008
K003086 · Concentric Medical, Inc.
DQO · Catheter, Intravascular, Diagnostic · 225d

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All categories 14968 DXN System, Measurement, Blood-pressure, Non-invasive 939 DQY Catheter, Percutaneous 792 DQX Wire, Guide, Catheter 701 DYB Introducer, Catheter 638 DPS Electrocardiograph 443 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 365 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