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
8376–8400 of 14981
Cleared Oct 24, 2000
LIFE SCOPE P, MODEL BSM-4100 SERIES
K001693 · Nihon Kohden America, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 144d
Cleared Oct 20, 2000
MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC
K002949 · Datascope Corp.
DSP · System, Balloon, Intra-aortic And Control · 29d
Cleared Oct 19, 2000
M2376A DEVICELINK SYSTEM
K003107 · Agilent Technologies, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 15d
Cleared Oct 18, 2000
GUNTHER TULIP VENA CAVA MREYE FILTER SET
K000855 · Cook, Inc.
DTK · Filter, Intravascular, Cardiovascular · 216d
Cleared Oct 18, 2000
PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V
K002204 · Pace Medical
DTE · Pulse-generator, Pacemaker, External · 90d
Cleared Oct 18, 2000
M2376A DEVICELINK SYSTEM, MODEL M2376A
K002967 · Agilent Technologies, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 26d
Cleared Oct 13, 2000
ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER
K001578 · AngioDynamics, Inc.
DQO · Catheter, Intravascular, Diagnostic · 144d
Cleared Oct 13, 2000
HL168B
K002882 · Health & Life Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 28d
Cleared Oct 13, 2000
SAFE MINI
K980974 · Polystan A/S
DTZ · Oxygenator, Cardiopulmonary Bypass · 942d
Cleared Oct 10, 2000
MODEL 4815 ADAPTER
K002496 · Pace Medical
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 57d
Cleared Oct 10, 2000
MODEL 4810 ANALYZER OUTPUT ADAPTER
K002497 · Pace Medical
DTC · Analyzer, Pacemaker Generator Function · 57d
Cleared Oct 05, 2000
CATHCOR DESKTOP
K002137 · Siemens Elema AB
DQK · Computer, Diagnostic, Programmable · 83d
Cleared Oct 05, 2000
S/5 COMPACT ANESTHESIA MONITOR WITH S-00A05, S-00A06. L-00A07, L00A08
K002478 · Datex-Ohmeda, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 55d
Cleared Oct 04, 2000
INQWIRE DIAGNOSTIC GUIDE WIRE
K002289 · Merit Medical Systems, Inc.
DQX · Wire, Guide, Catheter · 69d
Cleared Oct 04, 2000
PRESSURE WIRE SENSOR, MODEL 12003/12303
K002962 · Radi Medical Systems AB
DQX · Wire, Guide, Catheter · 12d
Cleared Sep 28, 2000
REBAR MICRO CATHETER: REBAR-10 (1.7F), 153 CM, DUAL MARKER BANDS
K002723 · Micro Therapeutics, Inc.
KRA · Catheter, Continuous Flush · 28d
Cleared Sep 27, 2000
TYSHAK, MODEL 102 AND Z-MED, MODEL 302
K991977 · NuMED, Inc.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 474d
Cleared Sep 26, 2000
CONSTELLATION CATHETERS
K000277 · Boston Scientific Corp
MTD · Catheter, Intracardiac Mapping, High-density Array · 239d
Cleared Sep 26, 2000
OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010
K000512 · Cas Medical Systems, Inc.
DXQ · Blood Pressure Cuff · 223d
Cleared Sep 26, 2000
BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D
K001244 · Citizen Watch Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 161d
Cleared Sep 25, 2000
ILT 0.014 CATHETER, MODEL C114NL2
K001992 · Intra Luminal Therapeutics, Inc.
DQY · Catheter, Percutaneous · 88d
Cleared Sep 21, 2000
4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER
K000825 · Medi-Dyne, Inc.
DQO · Catheter, Intravascular, Diagnostic · 191d
Cleared Sep 21, 2000
ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION
K002029 · Zoll Medical Corp
DXN · System, Measurement, Blood-pressure, Non-invasive · 80d
Cleared Sep 21, 2000
DINAMAP PRO 1000 MONITOR, MODEL 1000
K002248 · Critikon Company, LLC
DXN · System, Measurement, Blood-pressure, Non-invasive · 58d
Cleared Sep 20, 2000
VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS
K000664 · Baxter Healthcare Corp
DXG · Computer, Diagnostic, Pre-programmed, Single-function · 205d

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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