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.

18027
Total
17975
Cleared
150d
Avg (2y)
1976
Since
4350 Cardiovascular devices
3101–3125 of 4350
Cleared May 03, 2000
TEMPO AQUA ANGIOGRAPHIC CATHETER
K000579 · Cordis Corp.
DQO · Catheter, Intravascular, Diagnostic · 71d
Cleared Apr 28, 2000
CORDIS INTRODUCER GUIDE
K001136 · Cordis Corp.
DQY · Catheter, Percutaneous · 18d
Cleared Apr 27, 2000
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
K001138 · Medtronic Vascular
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 17d
Cleared Apr 17, 2000
MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT
K993677 · Medtronic Vascular
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 168d
Cleared Apr 13, 2000
BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA
K000570 · Boston Scientific Corp
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 51d
Cleared Apr 10, 2000
TRANSLUMINAL BALLOON DILATATION CATHETER
K993305 · Boston Scientific Corp
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 189d
Cleared Apr 07, 2000
RENEGADE HI-FLO MICROCATHETER
K000177 · Boston Scientific Corp
KRA · Catheter, Continuous Flush · 78d
Cleared Apr 06, 2000
CORDIS 13F CATHETER SHEATH INTRODUCER
K000753 · Cordis Corp.
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 29d
Cleared Mar 31, 2000
ENVOY AND VISTA BRITE TIP
K000715 · Cordis Corp.
DQY · Catheter, Percutaneous · 29d
Cleared Mar 29, 2000
ZUMA GUIDE CATHETERS
K000677 · Medtronic Vascular
DQY · Catheter, Percutaneous · 29d
Cleared Feb 28, 2000
MODIFICATION TO T-REX BIOPSY FORCEPS
K000409 · Boston Scientific Corp
DWZ · Device, Biopsy, Endomyocardial · 20d
Cleared Feb 25, 2000
AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511
K000430 · Medtronic Vascular
DTZ · Oxygenator, Cardiopulmonary Bypass · 16d
Cleared Feb 23, 2000
MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT
K000210 · Medtronic Vascular
DTD · Pacemaker Lead Adaptor · 30d
Cleared Feb 22, 2000
SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR
K993974 · Siemens Medical Solutions USA, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 90d
Cleared Feb 16, 2000
MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352
K000379 · Medtronic Vascular
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 9d
Cleared Feb 11, 2000
KODAK HOME HEALTH MONITORING SYSTEM
K983928 · Eastman Kodak Company
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 463d
Cleared Jan 21, 2000
REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR
K994331 · Medtronic Vascular
MXC · Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) · 29d
Cleared Jan 13, 2000
ATW MARKER WIRE STEERABLE GUIDEWIRE
K994358 · Cordis Corp.
DQX · Wire, Guide, Catheter · 17d
Cleared Jan 13, 2000
AESCULAP VASCULAR INSTRUMENTS
K992053 · Aesculap, Inc.
DXC · Clamp, Vascular · 209d
Cleared Jan 04, 2000
INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE
K994252 · Boston Scientific Corp
DYB · Introducer, Catheter · 18d
Cleared Dec 20, 1999
MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A
K993169 · Hewlett-Packard Co.
DRG · Transmitters And Receivers, Physiological Signal, Radiofrequency · 89d
Cleared Dec 01, 1999
HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A
K992977 · Hewlett-Packard Co.
MKJ · Automated External Defibrillators (non-wearable) · 89d
Cleared Nov 12, 1999
CONSTELLATION CATHETERS, MODEL 8039
K992777 · Boston Scientific Corp
MTD · Catheter, Intracardiac Mapping, High-density Array · 86d
Cleared Nov 08, 1999
HP M2600A VIRIDIA TELEMETRY SYSTEM
K993516 · Hewlett-Packard Co.
DSI · Detector And Alarm, Arrhythmia · 21d
Cleared Nov 05, 1999
ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE
K992373 · C.R. Bard, Inc.
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 113d

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All categories 4350 DXN System, Measurement, Blood-pressure, Non-invasive 241 DQY Catheter, Percutaneous 233 DYB Introducer, Catheter 195 DQX Wire, Guide, Catheter 188 DTB Permanent Pacemaker Electrode 187 DQK Computer, Diagnostic, Programmable 165 LIT Catheter, Angioplasty, Peripheral, Transluminal 138 DXY Implantable Pacemaker Pulse-generator 134 DQO Catheter, Intravascular, Diagnostic 121 QEW Peripheral Mechanical Thrombectomy With Aspiration 118 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 103 JOW Sleeve, Limb, Compressible 86 DPS Electrocardiograph 80 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 80 DTZ Oxygenator, Cardiopulmonary Bypass 72