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
14945 Cardiovascular devices
7476–7500 of 14945
Cleared Oct 15, 2004
SILICONE COATED GUIDEWIRE
K041740 · Arrow International, Inc.
DQX · Wire, Guide, Catheter · 109d
Cleared Oct 15, 2004
INTEGRATED PATIENT MONITORING SYSTEM
K041918 · Invivo Research, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 91d
Cleared Oct 15, 2004
3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000
K041934 · 3M Company
DQD · Stethoscope, Electronic · 88d
Cleared Oct 15, 2004
ENSITE SYSTEM, MODEL EE3000
K042493 · Endocardial Solutions, Inc.
DQK · Computer, Diagnostic, Programmable · 31d
Cleared Oct 15, 2004
EXCELSIOR 1018 AND SL-10 MICROCATHETERS
K042568 · Boston Scientific Corp
DQY · Catheter, Percutaneous · 24d
Cleared Oct 15, 2004
ACUSON ACUNAV 8F ULTRASOUND CATHETER
K042593 · Siemens Medical Solutions USA, Inc.
OBJ · Catheter, Ultrasound, Intravascular · 22d
Cleared Oct 15, 2004
GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3
K042771 · Datex-Ohmeda
MSX · System, Network And Communication, Physiological Monitors · 10d
Cleared Oct 13, 2004
AMLUCK, YA HORNG
K042581 · Ya Horng Electronic Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 21d
Cleared Oct 12, 2004
MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM
K042541 · Cryo Vascular Systems, Inc.
DQY · Catheter, Percutaneous · 22d
Cleared Oct 12, 2004
BIOMEDIX PADNET LAB
K042616 · Biomedix, Inc.
JOM · Plethysmograph, Photoelectric, Pneumatic Or Hydraulic · 19d
Cleared Oct 06, 2004
MPM SYSTEM
K041854 · Aerotel Medical Systems, Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 90d
Cleared Oct 06, 2004
EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE
K042060 · Millimed A/S
DTL · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass · 68d
Cleared Oct 06, 2004
CARDEON COBRA CATHETER
K042156 · Cardeon Corp.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 57d
Cleared Oct 06, 2004
BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER
K042469 · Braemar, Inc.
MWJ · Electrocardiograph, Ambulatory (without Analysis) · 23d
Cleared Oct 06, 2004
STELLAR 404 MONITORING SYSTEM
K042560 · Larsen & Toubro Limited
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 15d
Cleared Oct 06, 2004
INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5
K042656 · Draeger Medical Systems, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 8d
Cleared Oct 05, 2004
ZOLL M SERIES ETC02 LOFLO OPTION
K042417 · Zoll Medical Corp
MKJ · Automated External Defibrillators (non-wearable) · 28d
Cleared Sep 29, 2004
8600 VITAL SIGNS MONITOR
K042569 · Criticare Systems, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 8d
Cleared Sep 23, 2004
VASCULAR SOLUTIONS LANGSTON DUAL LUMEN PIGTAIL CATHETER (DLP)
K041909 · Vascular Solutions, Inc.
DQO · Catheter, Intravascular, Diagnostic · 70d
Cleared Sep 23, 2004
CLIPPER DIAGNOSTIC ELECTRODE CATHETER
K042105 · Bard Electrophysiology
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 50d
Cleared Sep 23, 2004
STOCKERT SCP RHYTHM
K042374 · Stockert Instrumente GmbH
DWA · Control, Pump Speed, Cardiopulmonary Bypass · 22d
Cleared Sep 23, 2004
Lysus Infusion System
K042456 · Ekos Corp.
QEY · Mechanical Thrombolysis Catheter · 13d
Cleared Sep 22, 2004
AMBU DISPOSABLE ECG ELECTRODE
K041734 · Ambu, Inc.
DRX · Electrode, Electrocardiograph · 89d
Cleared Sep 22, 2004
CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12
K041890 · Cryocor, Inc.
OCL · Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue · 72d
Cleared Sep 22, 2004
HOLTER PLUS
K042463 · Rozinn Electronics, Inc.
DQK · Computer, Diagnostic, Programmable · 9d

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All categories 14945 DXN System, Measurement, Blood-pressure, Non-invasive 937 DQY Catheter, Percutaneous 792 DQX Wire, Guide, Catheter 701 DYB Introducer, Catheter 637 DPS Electrocardiograph 443 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 413 DQO Catheter, Intravascular, Diagnostic 402 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 336 DSI Detector And Alarm, Arrhythmia 309 JOW Sleeve, Limb, Compressible 287 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 274