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
8626–8650 of 14992
Cleared Jan 28, 2000
SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS
K993667 · Sulzermedica
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 88d
Cleared Jan 27, 2000
RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
K993639 · Guidant Corp.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 91d
Cleared Jan 24, 2000
POWERHEART AECD
K993533 · Cardiac Science, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 97d
Cleared Jan 21, 2000
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR
K994331 · Medtronic Vascular
MXC · Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) · 29d
Cleared Jan 19, 2000
WATCH STYLE WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL: KLOCK
K991545 · Industrielle Entwicklung Medizintechnik Und Vertri
DXQ · Blood Pressure Cuff · 261d
Cleared Jan 18, 2000
MULTIFUNCTION KEITO K5
K984083 · Bumedco Intl., Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 428d
Cleared Jan 14, 2000
ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841
K992749 · Spacelabs Medical, Inc.
MSX · System, Network And Communication, Physiological Monitors · 151d
Cleared Jan 14, 2000
IBC FLOGUARD, MODEL 6050
K992785 · International Biophysics Corp.
MJJ · Cpb Check Valve, Retrograde Flow, In-line · 148d
Cleared Jan 13, 2000
AESCULAP VASCULAR INSTRUMENTS
K992053 · Aesculap, Inc.
DXC · Clamp, Vascular · 209d
Cleared Jan 13, 2000
VENAFLOW SYSTEM, MODEL 30A
K992454 · Aircast, Inc.
JOW · Sleeve, Limb, Compressible · 174d
Cleared Jan 13, 2000
PE 501 PC-ECG MONITOR
K992584 · Nhe Corp.
MWJ · Electrocardiograph, Ambulatory (without Analysis) · 164d
Cleared Jan 13, 2000
PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX
K993531 · Datascope Corp.
DSI · Detector And Alarm, Arrhythmia · 87d
Cleared Jan 13, 2000
AVIVA SYSTEM, MODEL SL1010
K993550 · American Telecare, Inc.
DRG · Transmitters And Receivers, Physiological Signal, Radiofrequency · 85d
Cleared Jan 13, 2000
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354
K994208 · Medtronic Perfusion Systems
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 30d
Cleared Jan 13, 2000
ATW MARKER WIRE STEERABLE GUIDEWIRE
K994358 · Cordis Corp.
DQX · Wire, Guide, Catheter · 17d
Cleared Jan 11, 2000
FLIPPER DETACHABLE EMBOLIZATION COIL
K993455 · Cook, Inc.
KRD · Device, Vascular, For Promoting Embolization · 90d
Cleared Jan 11, 2000
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z43
K993460 · Rossmax International , Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 90d
Cleared Jan 07, 2000
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z44
K993426 · Rossmax International , Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 87d
Cleared Jan 07, 2000
ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL Z40
K993429 · Rossmax International , Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 87d
Cleared Jan 06, 2000
BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP
K983866 · Belmont Instrument Corp.
DSP · System, Balloon, Intra-aortic And Control · 430d
Cleared Jan 05, 2000
ENSTYLET MODELS EC0010, EC0020
K993376 · Endocardial Solutions, Inc.
DRB · Stylet, Catheter · 90d
Cleared Jan 04, 2000
TFX MEDICAL INTRODUCER KIT
K991647 · Tfx Medical Group
DYB · Introducer, Catheter · 236d
Cleared Jan 04, 2000
REBAR MICRO CATHETER, MODELS 105-5080, 105-5086
K993672 · Micro Therapeutics, Inc.
KRA · Catheter, Continuous Flush · 64d
Cleared Jan 04, 2000
INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE
K994252 · Boston Scientific Corp
DYB · Introducer, Catheter · 18d
Cleared Dec 29, 1999
SULZER CARBOMEDICS CARDIOFIX PERICARDIUM
K993288 · Sulzer Carbomedics, Inc.
DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · 89d

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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