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
8201–8225 of 14968
Cleared Aug 14, 2001
MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
K012460 · Medtronic Vascular
LDF · Electrode, Pacemaker, Temporary · 13d
Cleared Aug 13, 2001
BACK-UP MEIER GUIDEWIRE
K011906 · Boston Scientific Corp
DQX · Wire, Guide, Catheter · 55d
Cleared Aug 10, 2001
CHASE CARDIOVASCULAR PATCH
K012248 · Chase Medical, Inc.
DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · 24d
Cleared Aug 02, 2001
CADENCE PRECISION INJECTOR, MODEL 103-0304
K011535 · Micro Therapeutics, Inc.
MJN · Catheter, Intravascular Occluding, Temporary · 76d
Cleared Aug 01, 2001
8100/8500 VITAL SIGNS MONITOR
K012059 · Criticare Systems, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 30d
Cleared Jul 31, 2001
ZOLL M SERIES IBP OPERATION
K011865 · Zoll Medical Corp
DSK · Computer, Blood-pressure · 47d
Cleared Jul 26, 2001
VIKING OPTIMA GUIDING CATHETER
K012002 · Guidant Corp.
DQY · Catheter, Percutaneous · 29d
Cleared Jul 25, 2001
STREERABLE PTCA GUIDEWIRE
K011968 · Lake Region Mfg., Inc.
DQX · Wire, Guide, Catheter · 30d
Cleared Jul 20, 2001
ROSSMAX SMARTINFLATE CARDIOPRO, MODEL 1000I AND MODEL 3000I BLOOD PRESSURE MONITORS
K011352 · Rossmax International , Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 78d
Cleared Jul 20, 2001
ROSSMAX MEDIPRO MODEL 100, MODEL 200, AND MODEL 300 BLOOD PRESSURE MONITORS
K011539 · Rossmax International , Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 63d
Cleared Jul 20, 2001
INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II
K012016 · Siemens Medical Solutions USA, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 22d
Cleared Jul 20, 2001
MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A
K012094 · Agilent Technologies, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 15d
Cleared Jul 20, 2001
BLOOD PRESSURE MONITOR (SPHYGMOMANOMETER), MODEL HT-110
K012194 · Nihon Seimitsu Sokki Co., Ltd.
DXQ · Blood Pressure Cuff · 7d
Cleared Jul 19, 2001
SPLITTABLE SHEATH INTRODUCER KIT
K004025 · Thomas Medical Products, Inc.
DYB · Introducer, Catheter · 204d
Cleared Jul 13, 2001
MALLEABLE SHAFT CLAMP
K011078 · Allegiance Healthcare Corp.
DXC · Clamp, Vascular · 95d
Cleared Jul 13, 2001
LIFESOURCE MODELS UA-787, UA 787PC, UA-787T
K012013 · A&D Engineering, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 15d
Cleared Jul 12, 2001
MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B
K011395 · Medtronic Vascular
KRH · Ring, Annuloplasty · 66d
Cleared Jul 12, 2001
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K011557 · NuMED, Inc.
DXF · Catheter, Septostomy · 52d
Cleared Jul 09, 2001
BRAIDED GUIDING INTRODUCER
K004026 · Thomas Medical Products, Inc.
DYB · Introducer, Catheter · 194d
Cleared Jul 09, 2001
GUIDEWIRE INTRODUCER SAFETY NEEDLE
K011085 · Medamicus, Inc.
DYB · Introducer, Catheter · 90d
Cleared Jul 09, 2001
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
K011804 · Terumo Cardiovascular Systems Corp.
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 28d
Cleared Jul 09, 2001
TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B
K011864 · Medtronic Vascular
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 25d
Cleared Jul 03, 2001
6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722
K011766 · St Jude Medical
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 26d
Cleared Jul 02, 2001
AGILENT M2636B TELEMON B MONITOR (TELEMON B)
K011824 · Agilent Technologies, Inc.
DSI · Detector And Alarm, Arrhythmia · 21d
Cleared Jun 29, 2001
TRAM 2001 MODULE
K011000 · General Electric Medical Systems Information Techn
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 87d

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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