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.

18151
Total
18097
Cleared
152d
Avg (2y)
1976
Since
14981 Cardiovascular devices
8351–8375 of 14981
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
Cleared Nov 17, 2000
TISSUE SPECTROSCOPE
K992529 · Vital Medical , Ltd.
DPW · Flowmeter, Blood, Cardiovascular · 478d
Cleared Nov 16, 2000
FRONT-LOAD POLYPROPYLENE SYRINGE
K001663 · Medrad, Inc.
DXT · Injector And Syringe, Angiographic · 169d
Cleared Nov 14, 2000
WELCH ALLYN SPOT CHECK DEVICE
K002530 · Welch Allyn, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 90d
Cleared Nov 09, 2000
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
K003179 · Siemens Medical Solutions USA, Inc.
DSI · Detector And Alarm, Arrhythmia · 29d
Cleared Nov 08, 2000
PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH
K002459 · Agilent Technologies, Inc.
DPS · Electrocardiograph · 90d
Cleared Nov 08, 2000
WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
K002473 · Nihon Kohden America, Inc.
DPS · Electrocardiograph · 89d
Cleared Nov 08, 2000
PERSONAL ECG TRANSMITTER, MODEL CG-6550
K003220 · Card Guard Scientific Survival , Ltd.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 23d
Cleared Nov 07, 2000
CNS-9300 SERIES CENTRAL STATION
K001433 · Nihon Kohden America, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 183d
Cleared Nov 07, 2000
ETHIBOND EXCEL VALVE LOOP SUTURE
K003070 · Ethicon, Inc.
DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · 36d
Cleared Nov 01, 2000
NUMED TYSHAK II AND Z-MED II PTV CATHETERS
K003052 · NuMED, Inc.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 30d
Cleared Nov 01, 2000
NUMED TYSHAK AND Z-MED PTV CATHETERS
K003114 · NuMED, Inc.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 27d
Cleared Nov 01, 2000
AB-180 XC SYSTEM, MODEL AB-180XC
K991783 · Cardiacassist, Inc.
KFM · Pump, Blood, Cardiopulmonary Bypass, Non-roller Type · 526d
Cleared Oct 30, 2000
RESPONDER 3000
K000638 · Ge Medical Systems Information Technologies GmbH
MKJ · Automated External Defibrillators (non-wearable) · 248d
Cleared Oct 30, 2000
KSEA VASCULAR FIBERSCOPES
K001408 · KARL STORZ Endoscopy-America, Inc.
LYK · Angioscope · 179d
Cleared Oct 30, 2000
CORDIS SLALOM PTA BALLOON CATHETER
K003159 · Cordis Corp.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 20d

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All categories 14981 DXN System, Measurement, Blood-pressure, Non-invasive 942 DQY Catheter, Percutaneous 792 DQX Wire, Guide, Catheter 702 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