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
14947 Cardiovascular devices
7526–7550 of 14947
Cleared Aug 24, 2004
MONITORING SYSTEM, MODEL ARGUS PB-2200
K033738 · Schiller AG
DSK · Computer, Blood-pressure · 270d
Cleared Aug 24, 2004
PIESOMETER, MODEL MK-1
K041169 · Canamet Canadian Natl Medical Technologies, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 112d
Cleared Aug 24, 2004
FORTIFIER DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL LF-01
K041400 · Fortifier International Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 90d
Cleared Aug 24, 2004
FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311
K042138 · Sein Electronics Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 15d
Cleared Aug 23, 2004
AIRGUARD VALVED INTRODUCER
K042036 · C.R. Bard, Inc.
DYB · Introducer, Catheter · 25d
Cleared Aug 18, 2004
WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE
K040490 · Welch Allyn, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 174d
Cleared Aug 16, 2004
MICRO PRIME
K041650 · Innovx Medical, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 60d
Cleared Aug 16, 2004
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K041973 · Intra Luminal Therapeutics, Inc.
DQX · Wire, Guide, Catheter · 25d
Cleared Aug 16, 2004
2 CM PERIPHERAL CUTTING BALOON
K041993 · Boston Scientific Ivt
PNO · Catheter, Percutaneous, Cutting/scoring · 24d
Cleared Aug 12, 2004
E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER
K042022 · Datrix, Inc. Dba of Jon Barron, Inc.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 15d
Cleared Aug 11, 2004
MODIFIED CONCENTRIC RETRIEVER, MODEL 90038
K040745 · Concentric Medical, Inc.
DQY · Catheter, Percutaneous · 141d
Cleared Aug 11, 2004
TERUMO CIRCUIT CONNECTORS
K041697 · Terumo Cardiovascular Systems Corporation
DTL · Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass · 50d
Cleared Aug 06, 2004
C3 AND LIFEGARD ICG IMPEDANCE CARDIOGRAPHY MONITORS
K041434 · Analogic Corp.
DSB · Plethysmograph, Impedance · 70d
Cleared Aug 06, 2004
LYSUS INFUSION SYSTEM
K041629 · Ekos Corp.
QEY · Mechanical Thrombolysis Catheter · 51d
Cleared Aug 06, 2004
POLYURETHANE BLOOD PRESSURE CUFFS
K041689 · D. E. Hokanson, Inc.
DXQ · Blood Pressure Cuff · 45d
Cleared Aug 06, 2004
FINISHING WIRE SUPPORTRAK
K041762 · Guidant Corporation
DQX · Wire, Guide, Catheter · 37d
Cleared Aug 06, 2004
PERMANENT PACING LEAD, MODEL PY2
K041809 · Oscor, Inc.
DTB · Permanent Pacemaker Electrode · 31d
Cleared Aug 06, 2004
DIGITAL BLOOD PRESSURE MONITOR, MODELS SE-9000, SE-9200 AND SE-9400
K042014 · Sein Electronics Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 10d
Cleared Aug 05, 2004
INFUSIONCATH
K041517 · Id, LLC
QEY · Mechanical Thrombolysis Catheter · 59d
Cleared Aug 03, 2004
ASAHI PTCA GUIDE WIRE CONFIANZA PRO
K041531 · Asahi Intecc Co., Ltd.
DQX · Wire, Guide, Catheter · 56d
Cleared Jul 28, 2004
EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE
K033463 · Edwards Lifesciences, LLC
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 271d
Cleared Jul 28, 2004
DATEX-OHMEDA PRESTN.01 MODULE (MODEL FAMILY M-PRESTN.01) AND ACCESSORIES
K041772 · Datex-Ohmeda
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 27d
Cleared Jul 23, 2004
MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456
K041727 · Boston Scientific Scimed, Inc.
OBJ · Catheter, Ultrasound, Intravascular · 28d
Cleared Jul 23, 2004
DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE03 AND LCANE03A SOFTWARE
K041790 · Datex-Ohmeda
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 21d
Cleared Jul 23, 2004
TRIO MONITOR
K041907 · Datascope Corp.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 8d

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All categories 14947 DXN System, Measurement, Blood-pressure, Non-invasive 938 DQY Catheter, Percutaneous 792 DQX Wire, Guide, Catheter 701 DYB Introducer, Catheter 637 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 336 DSI Detector And Alarm, Arrhythmia 309 JOW Sleeve, Limb, Compressible 287 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 274