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
14968 Cardiovascular devices
8251–8275 of 14968
Cleared May 16, 2001
CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F)
K003880 · Concentric Medical, Inc.
DQY · Catheter, Percutaneous · 152d
Cleared May 16, 2001
CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT
K011217 · Abbott Laboratories
DQO · Catheter, Intravascular, Diagnostic · 26d
Cleared May 14, 2001
IMPRA CARBOFLO EPTFE VASCULAR GRAFTS
K004012 · Impra, Inc.
DYF · Prosthesis, Vascular Graft, Of Less Then 6mm Diameter · 138d
Cleared May 10, 2001
MANDREL GUIDEWIRE ASSEMBLY
K011084 · Lake Region Mfg., Inc.
DQX · Wire, Guide, Catheter · 30d
Cleared May 08, 2001
ENVOY PATIENT MONITOR
K001120 · Mennen Medical , Ltd.
DSI · Detector And Alarm, Arrhythmia · 396d
Cleared May 04, 2001
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR
K011098 · Medtronic Vascular
MXC · Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) · 23d
Cleared May 03, 2001
ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
K002256 · Arrow Intl., Inc.
DSP · System, Balloon, Intra-aortic And Control · 282d
Cleared May 02, 2001
SYNETEC
K002817 · Ela Medical, Inc.
DQK · Computer, Diagnostic, Programmable · 233d
Cleared May 02, 2001
PTA-OS SIZING BALLOON, MODEL 360
K003320 · NuMED, Inc.
MJN · Catheter, Intravascular Occluding, Temporary · 190d
Cleared May 02, 2001
HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A
K003819 · Agilent Technologies, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 142d
Cleared May 01, 2001
AGILENT INFORMATION CENTER SOFTWARE FOR M3150,M3151,M3153 AND M3154
K011093 · Agilent Technologies, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 21d
Cleared Apr 27, 2001
GRAFT MARKER RING
K001915 · T. Korossurgical Instruments Corp.
MAB · Marker, Cardiopulmonary Bypass (vein Marker) · 308d
Cleared Apr 26, 2001
ATRIUM MEDICAL CORPORATION CLEARWAY PTFE BALLOON CATHETER
K002627 · Atrium Medical Corp.
DXE · Catheter, Embolectomy · 246d
Cleared Apr 26, 2001
COBE VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR, COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
K004046 · Cobe Cardiovascular, Inc.
DTP · Defoamer, Cardiopulmonary Bypass · 118d
Cleared Apr 20, 2001
NUMED HIGH PRESSURE PTA CATHETERS
K010880 · NuMED, Inc.
DQY · Catheter, Percutaneous · 28d
Cleared Apr 18, 2001
ILT DEFLECTING CATHETER, MODEL C114ND1
K010531 · Intra Luminal Therapeutics, Inc.
DQY · Catheter, Percutaneous · 54d
Cleared Apr 18, 2001
GUIDER SOFTIP GUIDING CATHETER XF 5F
K010853 · Boston Scientific, Target
DQY · Catheter, Percutaneous · 28d
Cleared Apr 12, 2001
CH 2000 CARDIAC DIAGNOSTIC SYSTEM
K010756 · Cambridge Heart, Inc.
DQK · Computer, Diagnostic, Programmable · 30d
Cleared Apr 12, 2001
HEARTWAVE ALTERNANS PROCESSING SYSTEM, APS
K010758 · Cambridge Heart, Inc.
DPS · Electrocardiograph · 30d
Cleared Apr 10, 2001
SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE
K003731 · Thomas Medical Products, Inc.
DYB · Introducer, Catheter · 127d
Cleared Apr 09, 2001
ICG MODULE
K010164 · General Electric Medical Systems Information Techn
DSB · Plethysmograph, Impedance · 81d
Cleared Apr 05, 2001
MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254
K010906 · Medtronic Vascular
DRB · Stylet, Catheter · 10d
Cleared Mar 30, 2001
RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET
K002019 · Sorin Group Italia S.R.L.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 270d
Cleared Mar 29, 2001
DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP
K010828 · A&D Engineering, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 9d
Cleared Mar 27, 2001
3M LITTMANN
K003723 · 3M Company
DQD · Stethoscope, Electronic · 113d

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All categories 14968 DXN System, Measurement, Blood-pressure, Non-invasive 939 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