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
14992 Cardiovascular devices
8601–8625 of 14992
Cleared Mar 01, 2000
CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING
K993189 · Terumo Corp.
DWE · Tubing, Pump, Cardiopulmonary Bypass · 160d
Cleared Mar 01, 2000
MIKRO-TIP ANGIOGRAPHIC CATHETER
K993694 · Millar Instruments, Inc.
DQO · Catheter, Intravascular, Diagnostic · 120d
Cleared Feb 28, 2000
MODIFICATION TO T-REX BIOPSY FORCEPS
K000409 · Boston Scientific Corp
DWZ · Device, Biopsy, Endomyocardial · 20d
Cleared Feb 28, 2000
ZOLL M SERIES ETCO2 OPTION
K993036 · Zoll Medical Corp
MKJ · Automated External Defibrillators (non-wearable) · 172d
Cleared Feb 25, 2000
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511
K000430 · Medtronic Vascular
DTZ · Oxygenator, Cardiopulmonary Bypass · 16d
Cleared Feb 25, 2000
CLEEN-ABLE
K994044 · Vital Signs, Inc.
DXQ · Blood Pressure Cuff · 88d
Cleared Feb 25, 2000
VERIPATH PERIPHERAL GUIDING CATHETER
K994229 · Advanced Cardiovascular Systems, Inc.
DQY · Catheter, Percutaneous · 71d
Cleared Feb 24, 2000
DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400
K992638 · Critikon Company, LLC
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 202d
Cleared Feb 23, 2000
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
K000210 · Medtronic Vascular
DTD · Pacemaker Lead Adaptor · 30d
Cleared Feb 22, 2000
LEMAITRE BALLOON CATHETER WITH IRRIGATION
K992940 · Vascutech, Inc.
DXE · Catheter, Embolectomy · 175d
Cleared Feb 22, 2000
SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR
K993974 · Siemens Medical Solutions USA, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 90d
Cleared Feb 18, 2000
IBC VRV, MODEL 1350
K992657 · International Biophysics Corp.
DWD · Suction Control, Intracardiac, Cardiopulmonary Bypass · 193d
Cleared Feb 18, 2000
8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
K993966 · Arrow Intl., Inc.
DSP · System, Balloon, Intra-aortic And Control · 87d
Cleared Feb 17, 2000
SJM TAILOR ANNULOPLASTY RING, MODEL TARN
K000119 · St. Jude Medical, Inc.
KRH · Ring, Annuloplasty · 30d
Cleared Feb 17, 2000
LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.) INFANT/NEWBORN HOLLOW FIBER OXYGENATOR
K991737 · Dideco S.P.A.
DTZ · Oxygenator, Cardiopulmonary Bypass · 272d
Cleared Feb 16, 2000
MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352
K000379 · Medtronic Vascular
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 9d
Cleared Feb 16, 2000
ABD VARISOFT STEERABLE GUIDE WIRE AND ABD VARISOFT GUIDE WIRE EXTENSION
K981936 · Advanced Biomedical Devices, Inc.
DQX · Wire, Guide, Catheter · 624d
Cleared Feb 11, 2000
CARD GUARD PERSONAL ELECTROCARDIOGRAM TRANSMITTER, MODEL CG-6206/6306
K000225 · Card Guard Scientific Survival , Ltd.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 18d
Cleared Feb 11, 2000
KODAK HOME HEALTH MONITORING SYSTEM
K983928 · Eastman Kodak Company
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 463d
Cleared Feb 10, 2000
RX VIATRAC 14 PERIPHERAL DILATATION CATHETER
K000101 · Guidant Corp.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 28d
Cleared Feb 10, 2000
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE
K000274 · Medtronic Cardiac Surgical Products
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 10d
Cleared Feb 08, 2000
ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE
K993818 · California Medical Laboratories, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 90d
Cleared Feb 03, 2000
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR MODELS M3000A, M3046A, M3015A, REL.B
K993383 · Hewlett-Packard GmbH
DSI · Detector And Alarm, Arrhythmia · 118d
Cleared Feb 03, 2000
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-80
K993745 · Katecho, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 90d
Cleared Jan 28, 2000
HP VIRIDIA MULTI-MEASUREMENT SERVER/COMPACT PORTABLE PATIENT MONITOR M3000A/M3046A/M3016A,REL B
K992273 · Hewlett-Packard GmbH
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 205d

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All categories 14992 DXN System, Measurement, Blood-pressure, Non-invasive 943 DQY Catheter, Percutaneous 792 DQX Wire, Guide, Catheter 702 DYB Introducer, Catheter 638 DPS Electrocardiograph 445 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 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