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.

18151
Total
18097
Cleared
152d
Avg (2y)
1976
Since
15029 Cardiovascular devices
9576–9600 of 15029
Cleared Mar 19, 1997
CHASE TWO STAGE VENOUS RETURN CATHETER
K964195 · Chase Medical, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 149d
Cleared Mar 19, 1997
CAHSE AORTIC ROOT CANNULA
K964198 · Chase Medical, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 149d
Cleared Mar 19, 1997
CHASE CORONARY SINUS PERFUSION CANNULA
K964199 · Chase Medical, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 149d
Cleared Mar 17, 1997
MEADOX EXXCEL EPTFE VASCULAR GRAFT
K962433 · Meadox Medicals, Div. Boston Scientific Corp.
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 266d
Cleared Mar 17, 1997
DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0
K964987 · Datascope Corp.
DSP · System, Balloon, Intra-aortic And Control · 94d
Cleared Mar 17, 1997
CARDIOBEEPER CB-12L
K965101 · Meridian Medical Technologies, Inc.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 87d
Cleared Mar 13, 1997
HOLTER DIGICORDER WITH PACER OPTION (MODEL 483)
K963174 · Del Mar Avionics
DSH · Recorder, Magnetic Tape, Medical · 211d
Cleared Mar 12, 1997
MS-2000
K961144 · Touritu Engineering Co., Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 356d
Cleared Mar 12, 1997
HEARTPORT NEEDLE TROCAR
K965051 · Heartport, Inc.
DRC · Trocar · 84d
Cleared Mar 11, 1997
VESSEL DILATOR
K963388 · Maxxim Medical
DRE · Dilator, Vessel, For Percutaneous Catheterization · 195d
Cleared Mar 11, 1997
EXACTRACE ADULT FOAM MONITORING ECG ELECTRODE CONMED MODEL 1510 AND INSTATRACE ADULT DIAPHORETIC FOAM ECG ELECTRODE CONM
K963787 · Conmedcorp
DRX · Electrode, Electrocardiograph · 172d
Cleared Mar 11, 1997
VISTA BRITE TIP CATHETERS
K965211 · Cordis Corp.
DQY · Catheter, Percutaneous · 74d
Not Cleared Mar 10, 1997
BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION
K964604 · Biotronik, Inc.
DTB · Permanent Pacemaker Electrode · 112d
Cleared Mar 10, 1997
VASCUTEK TWILLWEAVE VASCULAR GRAFT
K964959 · Vascutek, Ltd.
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 89d
Cleared Mar 10, 1997
GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR
K964973 · Gish Biomedical, Inc.
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 88d
Cleared Mar 07, 1997
MODEL 700
K944180 · Memtec Corp.
DSH · Recorder, Magnetic Tape, Medical · 924d
Cleared Mar 06, 1997
CARDIOSERV P
K962547 · Marquette Electronics, Inc.
DRO · Pacemaker, Cardiac, External Transcutaneous (non-invasive) · 251d
Cleared Mar 06, 1997
BIOCOR 200 HIGH PERFORMANCEOXYGENATOR
K964967 · Minntech Corp.
DTZ · Oxygenator, Cardiopulmonary Bypass · 86d
Cleared Mar 06, 1997
QUANTUM EDGE PEDIATRIC DEFIRBRILLATION ELECTRODES
K970391 · Contour Medical Technology, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 31d
Cleared Mar 05, 1997
PS-41 6M PATIENT SIMULATOR
K963198 · Metron U.S., Inc.
DPS · Electrocardiograph · 202d
Cleared Mar 04, 1997
OXIMETRIX 4 COMPUTER SYSTEM
K961661 · Abbott Laboratories
DXG · Computer, Diagnostic, Pre-programmed, Single-function · 308d
Cleared Mar 04, 1997
CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE
K965023 · Scimed Life Systems, Inc.
DQX · Wire, Guide, Catheter · 78d
Cleared Mar 04, 1997
NOAH MONITORING ELECTRODE SYSTEM
K970125 · Contour Medical Technology, Inc.
DRX · Electrode, Electrocardiograph · 49d
Cleared Feb 28, 1997
RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM
K963120 · Marquette Electronics, Inc.
DRO · Pacemaker, Cardiac, External Transcutaneous (non-invasive) · 200d
Cleared Feb 28, 1997
CARDIACMONITOR
K963375 · Vision Electronics
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 185d

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All categories 15029 DXN System, Measurement, Blood-pressure, Non-invasive 944 DQY Catheter, Percutaneous 795 DQX Wire, Guide, Catheter 703 DYB Introducer, Catheter 638 DPS Electrocardiograph 445 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 415 DQO Catheter, Intravascular, Diagnostic 404 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 381 LIT Catheter, Angioplasty, Peripheral, Transluminal 367 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 342 DSI Detector And Alarm, Arrhythmia 311 JOW Sleeve, Limb, Compressible 289 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 275