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
7776–7800 of 14954
Cleared Aug 01, 2003
CARDIOSOFT/CASE CARDIAC TESTING SYSTEM
K031561 · Ge Medical Systems Information Technologies
DQK · Computer, Diagnostic, Programmable · 74d
Cleared Aug 01, 2003
TERUMO AL8X ARTERIAL FILTER WITH X-COATING
K032128 · Terumo Cardiovascular Systems Corp.
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 22d
Cleared Aug 01, 2003
IQ HYDROPHILIC GUIDE WIRE
K032183 · Boston Scientific Corp
DQX · Wire, Guide, Catheter · 15d
Cleared Jul 31, 2003
MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB
K030671 · Medtronic Vascular
DQY · Catheter, Percutaneous · 150d
Cleared Jul 25, 2003
ELI 200+ AUDICOR
K031182 · Mortara Instrument, Inc.
DPS · Electrocardiograph · 101d
Cleared Jul 25, 2003
RECOVERY FILTER SYSTEM, MODEL RF-048F
K031328 · C.R. Bard, Inc.
DTK · Filter, Intravascular, Cardiovascular · 88d
Cleared Jul 25, 2003
MC2X MULTI-STAGE VENOUS CANNULA
K031776 · Medtronic Perfusion Systems
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 45d
Cleared Jul 23, 2003
RAPIDO CUT-AWAY CUTTER
K031459 · Guidant Corp.
DQY · Catheter, Percutaneous · 76d
Cleared Jul 22, 2003
EKOS PERIPHERAL INFUSION SYSTEM
K030637 · Ekos Corp.
QEY · Mechanical Thrombolysis Catheter · 144d
Cleared Jul 22, 2003
VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER
K031161 · Biosense Webster, Inc.
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 99d
Cleared Jul 22, 2003
PHILIPS TRACEMASTER ECG MANAGEMENT SYSTEM, MODELS M5100A AND M5101A
K032103 · Philips Medical Systems
DSH · Recorder, Magnetic Tape, Medical · 14d
Cleared Jul 18, 2003
APEEL CS CATHETER DELIVERY SYSTEM
K031906 · St Jude Medical
DYB · Introducer, Catheter · 28d
Cleared Jul 17, 2003
ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH
K031211 · Medtronic Vascular
DQY · Catheter, Percutaneous · 91d
Cleared Jul 16, 2003
DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES
K031376 · Ge Medical Systems Information Technologies
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 76d
Cleared Jul 15, 2003
SAFETY INTRODUCER NEEDLE
K030135 · B.Braun Medical, Inc.
DYB · Introducer, Catheter · 182d
Cleared Jul 11, 2003
ILT SAFE CROSS 0.035 SUPPORT CATHETER, MODEL C135SN1
K031417 · Intra Luminal Therapeutics, Inc.
DQY · Catheter, Percutaneous · 67d
Cleared Jul 09, 2003
IDEAL MIMESYS SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR
K032040 · Dideco S.P.A.
KFM · Pump, Blood, Cardiopulmonary Bypass, Non-roller Type · 8d
Cleared Jul 03, 2003
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291
K031422 · Philips Medical Systems
DPS · Electrocardiograph · 58d
Cleared Jul 02, 2003
ULTRAFLEX VENOUS CANNULA, MODEL 970XX AND CB970XX
K031827 · Medtronic Perfusion Systems
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 19d
Cleared Jul 01, 2003
HL168R
K031695 · Health & Life Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 29d
Cleared Jul 01, 2003
HL888RA
K031835 · Health & Life Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 29d
Cleared Jun 26, 2003
ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K031766 · Cook, Inc.
DQY · Catheter, Percutaneous · 17d
Cleared Jun 25, 2003
DATEX-OHMEDA PRESTN MODULE, (MODEL FAMILY M-PRESTN) AND ACCESSORIES
K031781 · Datex-Ohmeda
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 15d
Cleared Jun 20, 2003
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
K030944 · Edwards Lifesciences, LLC
DYB · Introducer, Catheter · 86d
Cleared Jun 19, 2003
PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV
K031164 · Oscor, Inc.
DTD · Pacemaker Lead Adaptor · 66d

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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