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
14971 Cardiovascular devices
8326–8350 of 14971
Cleared Dec 27, 2000
NUMED Z-MED PTV CATHERERS
K003643 · NuMED, Inc.
DQY · Catheter, Percutaneous · 30d
Cleared Dec 22, 2000
RESPONSE ELECTROPHYSIOLOGY CATHETER, SUPREME ELECTROPHYSIOLOGY CATHETER, MODEL 401XXX AND 401XXX
K002976 · St Jude Medical
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 88d
Cleared Dec 21, 2000
RI-SAN/RI-SANA BLOOD PRESSURE MANOMETERS
K002954 · Rudolf Riester GmbH & Co. KG
DXQ · Blood Pressure Cuff · 90d
Cleared Dec 21, 2000
EMPIRE N BLOOD PRESSURE MANOMETERS
K002955 · Rudolf Riester GmbH & Co. KG
DXQ · Blood Pressure Cuff · 90d
Cleared Dec 21, 2000
SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000
K003243 · Siemens Medical Solutions USA, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 65d
Cleared Dec 21, 2000
SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION
K003246 · Siemens Medical Solutions USA, Inc.
DSI · Detector And Alarm, Arrhythmia · 65d
Cleared Dec 21, 2000
SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER
K003248 · Siemens Medical Solutions USA, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 65d
Cleared Dec 21, 2000
PUMP TUBING WITH X-COATING
K003371 · Terumo Corp.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 52d
Cleared Dec 21, 2000
DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320
K003598 · Datascope Corp.
DSP · System, Balloon, Intra-aortic And Control · 30d
Cleared Dec 21, 2000
CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B
K003724 · Medtronic Vascular
DTR · Heat-exchanger, Cardiopulmonary Bypass · 17d
Cleared Dec 21, 2000
MSD EMBOLECTOMY BASKET
K991093 · Metamorphic Surgical Devices, LLC
QEW · Peripheral Mechanical Thrombectomy With Aspiration · 630d
Cleared Dec 20, 2000
HEARTSTREAM FR2 AED, MODEL M3860A,M3861A
K003565 · Agilent Technologies, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 30d
Cleared Dec 20, 2000
ST/AR ST AND ARRHYTHMIA SOFTWARE, MODEL RELEASE D.0
K003621 · Agilent Technologies, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 26d
Cleared Dec 18, 2000
M2376A DEVICELINK SYSTEM, MODEL M2376A
K003622 · Agilent Technologies, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 24d
Cleared Dec 14, 2000
K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
K003228 · Katecho, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 59d
Cleared Dec 06, 2000
AEDEFIBRILLATOR
K002232 · Medical Research Laboratories, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 135d
Cleared Dec 06, 2000
MODIFIED HYDROPHILIC COATED GUIDEWIRE (STAINLESS STEEL CORE)
K003483 · Lake Region Mfg., Inc.
DQX · Wire, Guide, Catheter · 27d
Cleared Dec 05, 2000
SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS
K002105 · Siemens Medical Solutions USA, Inc.
MLD · Monitor, St Segment With Alarm · 146d
Cleared Dec 01, 2000
TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107
K003276 · NuMED, Inc.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 43d
Cleared Nov 30, 2000
DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER
K002493 · Cobe Cardiovascular, Inc.
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 108d
Cleared Nov 29, 2000
ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509
K000004 · Daig Corp.
DYB · Introducer, Catheter · 331d
Cleared Nov 22, 2000
PC ECG 1200
K000404 · Norav Medical , Ltd.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 289d
Cleared Nov 21, 2000
K-DEFIB/PACE, MODEL KDP-60A
K002806 · Katecho, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 74d
Cleared Nov 21, 2000
PINNACLE R/O II OR RADIFOCUS INTRODUCER II
K003424 · Terumo Medical Corp.
DYB · Introducer, Catheter · 18d
Cleared Nov 21, 2000
MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR
K003444 · Nihon Seimitsu Sokki Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 15d

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All categories 14971 DXN System, Measurement, Blood-pressure, Non-invasive 941 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