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
8276–8300 of 14971
Cleared Mar 27, 2001
3M LITTMANN
K003723 · 3M Company
DQD · Stethoscope, Electronic · 113d
Cleared Mar 27, 2001
IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS
K004011 · Impra, Inc.
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 90d
Cleared Mar 26, 2001
FOGARTY VALVULOTOME, MODEL 700091
K001734 · Edwards Lifesciences, LLC
MGZ · Valvulotome · 292d
Cleared Mar 23, 2001
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT - HEAT EXCHANGER COILS
K000977 · Olson Medical Sales, Inc.
DTR · Heat-exchanger, Cardiopulmonary Bypass · 361d
Cleared Mar 22, 2001
LDOB OCCLUSION BALLOON CATHETER
K002286 · Cook, Inc.
MJN · Catheter, Intravascular Occluding, Temporary · 238d
Cleared Mar 22, 2001
SILVERSPEED HYDROPHILIC GUIDEWIRE, MODELS 103-0601-300 AND 103-0602-300
K010497 · Micro Therapeutics, Inc.
DQX · Wire, Guide, Catheter · 29d
Cleared Mar 21, 2001
TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT
K002507 · Arrow Intl., Inc.
DYB · Introducer, Catheter · 218d
Cleared Mar 20, 2001
SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER
K010640 · Siemens Medical Solutions USA, Inc.
DRQ · Amplifier And Signal Conditioner, Transducer Signal · 15d
Cleared Mar 19, 2001
WRISTWATCH BPM BLOOD PRESSURE MONITOR, MODEL KP-6120
K002665 · K-Jump Health Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 206d
Cleared Mar 16, 2001
COOK PRESSURE MONITORING CATHETER
K002254 · Cook, Inc.
DQO · Catheter, Intravascular, Diagnostic · 234d
Cleared Mar 15, 2001
GALIX GBI -3S-LP
K992706 · Galix Biomedical Instrumentation, Inc.
MLO · Electrocardiograph, Ambulatory, With Analysis Algorithm · 581d
Cleared Mar 09, 2001
ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R2000-CMS
K010390 · Acist Medical Systems, Inc.
DXT · Injector And Syringe, Angiographic · 28d
Cleared Mar 07, 2001
SUPERCROSS CATHETER
K001856 · Abbott Vascular, Inc.
DQY · Catheter, Percutaneous · 261d
Cleared Mar 07, 2001
CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020
K003085 · Concentric Medical, Inc.
DQY · Catheter, Percutaneous · 155d
Cleared Mar 02, 2001
ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U
K010330 · Arrow Intl., Inc.
DSP · System, Balloon, Intra-aortic And Control · 28d
Cleared Mar 02, 2001
M2376A DEVICELINK SYSTEM
K010453 · Agilent Technologies, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 15d
Cleared Mar 01, 2001
ASTRONOMER+WITH SLD
K003362 · Boston Scientific Corp
DQK · Computer, Diagnostic, Programmable · 125d
Cleared Mar 01, 2001
MODIFICATION TO: AGILITY STEERABLE GUIDEWIRES
K010511 · Cordis Neurovascular, Inc.
DQX · Wire, Guide, Catheter · 8d
Cleared Feb 28, 2001
ZOLL M SERIES
K010257 · Zoll Medical Corp
MKJ · Automated External Defibrillators (non-wearable) · 30d
Cleared Feb 14, 2001
REVEAL PLUS INSERTABLE LOOP RECORDER
K003667 · Medtronic Vascular
MXC · Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) · 78d
Cleared Feb 14, 2001
CONSTELLATION CATHETER, MODEL 8031
K003782 · Boston Scientific Corp
MTD · Catheter, Intracardiac Mapping, High-density Array · 69d
Cleared Feb 14, 2001
M2376A DEVICELINK SYSTEM, MODEL M2376A
K010342 · Agilent Technologies, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 9d
Cleared Feb 13, 2001
FLOWRIDER FLOW DIRECTED MICRO CATHETER, MODEL 105-5065
K010004 · Micro Therapeutics, Inc.
KRA · Catheter, Continuous Flush · 42d
Cleared Feb 13, 2001
BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K010169 · C.R. Bard, Inc.
DQY · Catheter, Percutaneous · 26d
Cleared Feb 08, 2001
ORG-9200A
K002068 · Nihon Kohden America, Inc.
DSI · Detector And Alarm, Arrhythmia · 216d

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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