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
8301–8325 of 14971
Cleared Feb 08, 2001
STYLET KIT, MODELS 6254,6282,6293
K003535 · Medtronic Vascular
DRB · Stylet, Catheter · 84d
Cleared Feb 07, 2001
MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP
K000776 · Medtronic Cardiac Surgical Products
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 334d
Cleared Feb 07, 2001
ADAPTERS WITH X-COATING
K003604 · Terumo Cardiovascular Systems Corp.
DTL · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass · 78d
Cleared Feb 05, 2001
PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
K002280 · Medical Devices, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 194d
Cleared Feb 01, 2001
M2376A DEVICELINK SYSTEM
K010048 · Agilent Technologies, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 27d
Cleared Feb 01, 2001
BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE
K990284 · Baylis Medical Co., Inc.
DXF · Catheter, Septostomy · 734d
Cleared Jan 30, 2001
APPALEAD GW+03XXXXXXR SERIES
K003394 · Nipro Medical Corp.
DQX · Wire, Guide, Catheter · 90d
Cleared Jan 29, 2001
BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520
K001543 · Welch Allyn, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 257d
Cleared Jan 29, 2001
CHASE CARDIOVASCULAR PATCH
K003467 · Chase Medical, Inc.
DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · 82d
Cleared Jan 25, 2001
INTRODEUCE DOUBLE LUMEN INTRODUCER
K001985 · Cook, Inc.
DYB · Introducer, Catheter · 210d
Cleared Jan 25, 2001
Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503
K003576 · Quinton, Inc.
DSI · Detector And Alarm, Arrhythmia · 66d
Cleared Jan 19, 2001
A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
K002061 · A&D Engineering, Inc.
DRT · Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · 197d
Cleared Jan 19, 2001
TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B
K003964 · Cordis Corp.
DTK · Filter, Intravascular, Cardiovascular · 28d
Cleared Jan 18, 2001
A1-CS-SB Y-ADAPTER, MODEL 124 871
K003454 · Biotronik, Inc.
DTD · Pacemaker Lead Adaptor · 72d
Cleared Jan 18, 2001
ANALYTIC SPECTRAL METHOD OF ALTERNANS PROCESSING
K003492 · Cambridge Heart, Inc.
DQK · Computer, Diagnostic, Programmable · 66d
Cleared Jan 17, 2001
ANGIODYNAMICS SOFT-VU SIZING ANGIOGRAPHIC CATHETER
K003901 · AngioDynamics, Inc.
DQO · Catheter, Intravascular, Diagnostic · 30d
Cleared Jan 11, 2001
RADIANALYZER, MODEL 12710
K002067 · Radi Medical Systems AB
DSK · Computer, Blood-pressure · 188d
Cleared Jan 11, 2001
MULTITRACK ANGIOGRAPHIC CATHETER
K003902 · NuMED, Inc.
DQO · Catheter, Intravascular, Diagnostic · 23d
Cleared Jan 11, 2001
NUMED GHOST II PTA CATHETERS
K003972 · NuMED, Inc.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 20d
Cleared Jan 09, 2001
VENODYNE DVT ADVANTAGE MODEL 610
K001802 · Microtek Medical, Inc.
JOW · Sleeve, Limb, Compressible · 209d
Cleared Jan 09, 2001
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
K003072 · Biotronik, Inc.
DTB · Permanent Pacemaker Electrode · 98d
Cleared Jan 08, 2001
PROWLER INFUSION CATHETERS WITH PRE-SHAPED TIPS
K003925 · Cordis Neurovascular, Inc.
KRA · Catheter, Continuous Flush · 19d
Cleared Jan 08, 2001
INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS
K990800 · Intervascular, Inc.
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 670d
Cleared Jan 03, 2001
ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F),
K003729 · St Jude Medical
DYB · Introducer, Catheter · 30d
Cleared Dec 27, 2000
SURGISIS PERIPHERAL VASCULAR PATCH
K001785 · Cook Biotech, Inc.
DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · 197d

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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