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
14783 Cardiovascular devices
4951–4975 of 14783
Cleared Nov 09, 2011
RUBICON SUPPORT CATHETER
K112303 · Boston Scientific
DQY · Catheter, Percutaneous · 90d
Cleared Nov 09, 2011
PATIENT MONITOR
K112190 · Mediana Co., Ltd.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 103d
Cleared Nov 09, 2011
POWERPRESS UNIT
K110276 · Hanuri Distribution, Inc.
JOW · Sleeve, Limb, Compressible · 282d
Cleared Nov 08, 2011
HI-TORQUE POWERTURN
K112957 · Abbott Vascular-Cardiac Therapies
DQX · Wire, Guide, Catheter · 35d
Cleared Nov 04, 2011
M VISUM ALERT ALARM MANAGEMENT SYSTEM
K112282 · Mvisum, Inc.
MSX · System, Network And Communication, Physiological Monitors · 87d
Cleared Nov 03, 2011
HI TORQUE CONNECT GUIDEWIRE
K112381 · Lake Region Medical
DQX · Wire, Guide, Catheter · 78d
Cleared Nov 02, 2011
SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
K112962 · Spacelabs Medical, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 28d
Cleared Nov 02, 2011
REFLEX BALLON GUIDE CATHETER
K112262 · Reverse Medical Corporation
DQY · Catheter, Percutaneous · 86d
Cleared Nov 02, 2011
FOURSNARE VASCULAR RETRIEVAL SNARE
K112185 · Cook, Inc.
MMX · Device, Percutaneous Retrieval · 96d
Cleared Oct 28, 2011
PHILIPS HEARTSTART FR3 AUTOMATED EXTERNAL DEFIBRILLATOR
K111693 · Philips Medical Systems
MKJ · Automated External Defibrillators (non-wearable) · 134d
Cleared Oct 27, 2011
ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID
K112917 · Medtronic, Inc.
DQY · Catheter, Percutaneous · 24d
Cleared Oct 27, 2011
VSI GUIDEWIRE
K112631 · Vascular Solutions, Inc.
DQX · Wire, Guide, Catheter · 48d
Cleared Oct 27, 2011
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
K111723 · Ev3, Inc.
MCW · Catheter, Peripheral, Atherectomy · 129d
Cleared Oct 27, 2011
ZOLL RESCUENETLINK
K111296 · Zoll Medical Corporation, World Wide Headquarters
MSX · System, Network And Communication, Physiological Monitors · 171d
Cleared Oct 27, 2011
SPIDERFX EMBOLIC PROTECTION DEVICE
K111010 · Ev3, Inc.
NTE · Temporary Carotid Catheter For Embolic Capture · 199d
Cleared Oct 25, 2011
REVIVE INTERMEDIATE CATHETER (REVIVE IC)
K112828 · Codman & Shurtleff, Inc.
DQY · Catheter, Percutaneous · 27d
Cleared Oct 24, 2011
PATIENT MONITOR
K112803 · Guangdong Biolight Meditech Co., Ltd.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 27d
Cleared Oct 24, 2011
MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT
K112497 · C.R. Bard, Inc.
DTK · Filter, Intravascular, Cardiovascular · 56d
Cleared Oct 24, 2011
AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
K110569 · Inovise Medical, Inc.
MLO · Electrocardiograph, Ambulatory, With Analysis Algorithm · 238d
Cleared Oct 21, 2011
REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER
K112292 · Stryker Sustainability Solutions
NLH · Catheter, Recording, Electrode, Reprocessed · 72d
Cleared Oct 21, 2011
AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER
K111854 · St. Jude Medical Systems AB
DRG · Transmitters And Receivers, Physiological Signal, Radiofrequency · 114d
Cleared Oct 21, 2011
PHYSIOGLOVE ES WITH ECG ANALYSIS
K103791 · Commwell , Ltd.
DPS · Electrocardiograph · 298d
Cleared Oct 20, 2011
OSTAR USB BLOOD PRESSURE MONITOR WITH SPECTRUM / P200 FOR UPPER ARM, AND M100 FOR WRIST TYPE
K112269 · OSTAR MEDITECH CORP.
DXN · System, Measurement, Blood-pressure, Non-invasive · 73d
Cleared Oct 20, 2011
DELTEX MEDICAL CARDIOQ EDM
K111542 · Deltex Medical Limited
DPW · Flowmeter, Blood, Cardiovascular · 140d
Cleared Oct 20, 2011
NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE
K110315 · Nexgen Medical Systems, Inc.
QEZ · Aspiration Thrombectomy Catheter · 260d

Looking for a specific cardiovascular device? Search by device name, K-number or manufacturer.

Search all Cardiovascular 510(k) devices

Filter by Product Code

All categories 14783 DXN System, Measurement, Blood-pressure, Non-invasive 924 DQY Catheter, Percutaneous 786 DQX Wire, Guide, Catheter 698 DYB Introducer, Catheter 626 DPS Electrocardiograph 436 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 409 DQO Catheter, Intravascular, Diagnostic 400 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 375 LIT Catheter, Angioplasty, Peripheral, Transluminal 357 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 336 DSI Detector And Alarm, Arrhythmia 306 JOW Sleeve, Limb, Compressible 272 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 266