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
14967 Cardiovascular devices
8176–8200 of 14967
Cleared Sep 12, 2001
NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES
K011918 · Nihon Kohden America, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 84d
Cleared Sep 12, 2001
ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825
K011980 · Pace Medical
DTE · Pulse-generator, Pacemaker, External · 79d
Cleared Sep 10, 2001
CG-2211 SELFCHECK ECG TRANSMITTER
K012223 · Card Guard Scientific Survival , Ltd.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 56d
Cleared Sep 06, 2001
VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER
K012050 · Guidant Corp.
DQY · Catheter, Percutaneous · 66d
Cleared Sep 05, 2001
MICROCRUISER PLUS INTRODUCER SET
K011790 · Medical Device Technologies, Inc.
DYB · Introducer, Catheter · 89d
Cleared Sep 04, 2001
DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260
K012392 · Pace Medical
DSA · Cable, Transducer And Electrode, Patient, (including Connector) · 39d
Cleared Aug 30, 2001
ILT SUPPORT CATHETER .014, MODEL C114LW1
K012169 · Intra Luminal Therapeutics, Inc.
DQY · Catheter, Percutaneous · 49d
Cleared Aug 28, 2001
SNIPER ELITE MODEL-OR-E3872XX SERIES
K011905 · Maxxim Medical
DQX · Wire, Guide, Catheter · 70d
Cleared Aug 28, 2001
ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218
K012083 · Medtronic Vascular
DQY · Catheter, Percutaneous · 56d
Cleared Aug 28, 2001
ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM
K012130 · Medtronic Vascular
DQY · Catheter, Percutaneous · 50d
Cleared Aug 28, 2001
ATTAIN 6215 VENOGRAM BALLOON CATHETER
K012225 · Medtronic Vascular
DYG · Catheter, Flow Directed · 43d
Cleared Aug 23, 2001
TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE
K012538 · Medtronic Vascular
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 16d
Cleared Aug 22, 2001
MONARCH INFLATION SYRINGE
K011811 · Merit Medical Systems, Inc.
DXT · Injector And Syringe, Angiographic · 72d
Cleared Aug 22, 2001
MODIFICATION TO:HL168D BLOOD PRESSURE MONITOR
K012310 · Health & Life Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 30d
Cleared Aug 21, 2001
KSEA DION-GRACIA SET
K010785 · KARL STORZ Endoscopy-America, Inc.
DXC · Clamp, Vascular · 159d
Cleared Aug 21, 2001
MODIFICATION TO MEDRAD SPECTRIS MR INJECTOR
K011991 · Medrad, Inc.
DXT · Injector And Syringe, Angiographic · 56d
Cleared Aug 17, 2001
WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
K012455 · Welch Allyn, Inc.
DXQ · Blood Pressure Cuff · 16d
Cleared Aug 17, 2001
SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER
K012461 · Siemens Medical Solutions USA, Inc.
DSI · Detector And Alarm, Arrhythmia · 16d
Cleared Aug 16, 2001
MODIFICATION TO ENVOY PATIENT MONITOR
K011784 · Mennen Medical , Ltd.
DSI · Detector And Alarm, Arrhythmia · 69d
Cleared Aug 15, 2001
CAPIOX SP PUMP WITH X-COATING PRODUCT CODE: CXSP45X
K012209 · Terumo Cardiovascular Systems Corp.
KFM · Pump, Blood, Cardiopulmonary Bypass, Non-roller Type · 30d
Cleared Aug 14, 2001
CG-3250 MINIRECEIVER
K012187 · Card Guard Scientific Survival , Ltd.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 33d
Cleared Aug 14, 2001
MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD
K012452 · Medtronic Vascular
LDF · Electrode, Pacemaker, Temporary · 13d
Cleared Aug 14, 2001
MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD
K012454 · Medtronic Vascular
LDF · Electrode, Pacemaker, Temporary · 13d
Cleared Aug 14, 2001
MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD
K012458 · Medtronic Vascular
LDF · Electrode, Pacemaker, Temporary · 13d
Cleared Aug 14, 2001
MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE
K012459 · Medtronic Vascular
LDF · Electrode, Pacemaker, Temporary · 13d

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All categories 14967 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