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
14998 Cardiovascular devices
8751–8775 of 14998
Cleared Oct 01, 1999
ADVANTA GRAFT (<6MM)
K992958 · Atrium Medical Corp.
DYF · Prosthesis, Vascular Graft, Of Less Then 6mm Diameter · 29d
Cleared Oct 01, 1999
ADVANTA GRAFT (>6MM)
K992960 · Atrium Medical Corp.
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 29d
Cleared Sep 29, 1999
WORKHORSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER
K991540 · AngioDynamics, Inc.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 149d
Cleared Sep 29, 1999
KENDALL MODEL 7325 SCD RESPONSE COMPRESSION SYSTEM, MODEL 7325
K992079 · The Kendall Company, L.P.
JOW · Sleeve, Limb, Compressible · 100d
Cleared Sep 29, 1999
INTRAMAX ITI GUIDE CATHETER
K992622 · Intratherapeutics, Inc.
DQY · Catheter, Percutaneous · 55d
Cleared Sep 29, 1999
CARTO EP NAVIGATION SYSTEM
K992968 · Biosense Webster, Inc.
DQK · Computer, Diagnostic, Programmable · 26d
Cleared Sep 23, 1999
AGILITY STEERABLE GUIDEWIRE
K991646 · Cordis Neurovascular, Inc.
DQX · Wire, Guide, Catheter · 133d
Cleared Sep 20, 1999
STATVIEW SYSTEM
K990378 · Data Critical Corp.
MSX · System, Network And Communication, Physiological Monitors · 224d
Cleared Sep 20, 1999
HOLLOW FIBER MEMBRANE OYGENATOR QUADROX HMO 1010
K992559 · Jostra Bentley
DTZ · Oxygenator, Cardiopulmonary Bypass · 52d
Cleared Sep 17, 1999
CARDIOPHONICS 1000 MEMORY MONITOR
K992772 · Rlt Medical Assoc., Inc.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 30d
Cleared Sep 16, 1999
BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM
K983717 · Aerotel Medical Systems (1998) , Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 330d
Cleared Sep 16, 1999
ECHOFLOW DOPPLER BLOOD VELOCITY METER
K990642 · Echocath, Inc.
JOP · Transducer, Ultrasonic · 202d
Cleared Sep 15, 1999
PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
K983196 · Tz Medical, Inc.
DRO · Pacemaker, Cardiac, External Transcutaneous (non-invasive) · 369d
Cleared Sep 15, 1999
PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT
K983232 · Tz Medical, Inc.
DRO · Pacemaker, Cardiac, External Transcutaneous (non-invasive) · 366d
Cleared Sep 15, 1999
CORDIS EXTREME PTA BALLOON CATHETER
K992825 · Cordis Corp.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 23d
Cleared Sep 15, 1999
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B)
K992910 · Medtronic Vascular
DTZ · Oxygenator, Cardiopulmonary Bypass · 16d
Cleared Sep 14, 1999
MADTRONIC DLP ARTERIAL CANNULAE
K991066 · Medtronic Vascular
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 167d
Cleared Sep 09, 1999
MEDTRONIC GT2 FUSION GUIDE WIRES
K992237 · Medtronic Vascular
DQX · Wire, Guide, Catheter · 69d
Cleared Sep 08, 1999
PTFE RINGED GORE-TEX VASCULAR GRAFT
K991683 · W.L. Gore & Associates, Inc.
DYF · Prosthesis, Vascular Graft, Of Less Then 6mm Diameter · 114d
Cleared Sep 08, 1999
SLIMLINE SURGICAL CLAMP
K992640 · Minumys Surgical, Inc.
DXC · Clamp, Vascular · 33d
Cleared Sep 03, 1999
MODIFICATION OF NOGA
K990494 · Biosense, Inc.
DQK · Computer, Diagnostic, Programmable · 198d
Cleared Sep 03, 1999
ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC)
K990762 · Zoll Medical Corp
MKJ · Automated External Defibrillators (non-wearable) · 179d
Cleared Sep 03, 1999
LIFEPAK 12 BIPHASIC
K991910 · Physio-Control Corp.
MKJ · Automated External Defibrillators (non-wearable) · 88d
Cleared Sep 03, 1999
CAPIOX SX10 HARDSHELL RESEVOIR
K991973 · Terumo Medical Corp.
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 84d
Cleared Sep 01, 1999
NIBP AND CO2 OPTIONS FOR THE PHYSIO-CONTROL LIFEPAK 12 DEFIBRILLATOR/MONITOR SYSTEM
K990338 · Physio-Control Corp.
DXN · System, Measurement, Blood-pressure, Non-invasive · 210d

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All categories 14998 DXN System, Measurement, Blood-pressure, Non-invasive 943 DQY Catheter, Percutaneous 792 DQX Wire, Guide, Catheter 703 DYB Introducer, Catheter 638 DPS Electrocardiograph 445 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 414 DQO Catheter, Intravascular, Diagnostic 404 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 377 LIT Catheter, Angioplasty, Peripheral, Transluminal 367 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