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
14954 Cardiovascular devices
7801–7825 of 14954
Cleared Jun 18, 2003
ULTRA HIGH PRESSURE INJECTOR LINES
K023591 · Deroyal Industries, Inc.
DQO · Catheter, Intravascular, Diagnostic · 236d
Cleared Jun 11, 2003
DISPOSABLE TEMPORARY PACING WIRE
K023174 · River Medical, Inc.
LDF · Electrode, Pacemaker, Temporary · 261d
Cleared Jun 10, 2003
DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
K031569 · Datascope Corp.
DSP · System, Balloon, Intra-aortic And Control · 21d
Cleared Jun 06, 2003
SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM
K030738 · Siemens Medical Solutions USA, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 88d
Cleared Jun 06, 2003
AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506
K031479 · Datex-Ohmeda, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 29d
Cleared Jun 06, 2003
PRESSURE WIRE SENSOR, MODELS 12004/12304
K031662 · Radi Medical Systems AB
DXO · Transducer, Pressure, Catheter Tip · 9d
Cleared Jun 03, 2003
LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0
K031000 · C.R. Bard, Inc.
DQK · Computer, Diagnostic, Programmable · 64d
Cleared May 30, 2003
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATING
K030726 · Gish Biomedical, Inc.
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 84d
Cleared May 30, 2003
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1
K031403 · Philips Medical Systems, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 25d
Cleared May 29, 2003
PACEART SYSTEM
K024278 · Medtronic Vascular
DPS · Electrocardiograph · 157d
Cleared May 23, 2003
AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR)
K030230 · Avita Corporation
DXN · System, Measurement, Blood-pressure, Non-invasive · 121d
Cleared May 23, 2003
CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221
K030398 · Cardiacassist, Inc.
DQR · Cannula, Catheter · 106d
Cleared May 22, 2003
MODEL 5071 MYOCARDIAL PACING LEAD
K031274 · Medtronic Vascular
DTB · Permanent Pacemaker Electrode · 30d
Cleared May 22, 2003
EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX,
K031518 · Medtronic Vascular
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 7d
Cleared May 21, 2003
MODIFICATION TO NUMED TYSHAK II AND Z-MED II PTV CATHETERS
K030589 · NuMED, Inc.
DQY · Catheter, Percutaneous · 85d
Cleared May 21, 2003
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
K030617 · Boston Scientific Scimed, Inc.
DQX · Wire, Guide, Catheter · 84d
Cleared May 21, 2003
DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-AN03 AND L-ANE03A SOFTWARE
K030812 · Datex-Ohmeda
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 68d
Cleared May 20, 2003
IS-1 HEMOSTASIS VALVE, MODEL 6799
K031398 · Guidant Corp.
DTL · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass · 15d
Cleared May 14, 2003
CAPIOX CARDIOTOMY RESERVOIR
K030505 · Terumo Cardiovascular Systems Corp.
DPW · Flowmeter, Blood, Cardiovascular · 84d
Cleared May 14, 2003
IBC FLOPUMP WITH GBS COATING
K031300 · Gish Biomedical, Inc.
KFM · Pump, Blood, Cardiopulmonary Bypass, Non-roller Type · 20d
Cleared May 13, 2003
DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000
K022834 · Ge Medical Systems Information Technologies
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 260d
Cleared May 13, 2003
EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE
K031037 · Medtronic Perfusion Systems
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 42d
Cleared May 09, 2003
DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES (SWITCHED-LARGE), DISPOSABLE STERILE INTERNAL DEFIBRILLATION PADDLES
K030417 · Philips Medical Systems
LDD · Dc-defibrillator, Low-energy, (including Paddles) · 88d
Cleared May 09, 2003
C3 PATIENT MONITOR
K030931 · Analogic Corp.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 45d
Cleared May 06, 2003
EK-PRO ARRHYTHMIA DETECTION ALGORITHM
K031320 · Ge Medical Systems Information Technologies
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 11d

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All categories 14954 DXN System, Measurement, Blood-pressure, Non-invasive 938 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 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 337 DSI Detector And Alarm, Arrhythmia 309 JOW Sleeve, Limb, Compressible 288 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 275