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
14967 Cardiovascular devices
8126–8150 of 14967
Cleared Dec 13, 2001
MEDRAD QWIK-FIT SYRINGE
K013815 · Medrad, Inc.
DXT · Injector And Syringe, Angiographic · 27d
Cleared Dec 11, 2001
CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH/WITHOUT HARDSHELL RESERVOIR WITH X-COATING
K010443 · Terumo Cardiovascular Systems Corp.
DTZ · Oxygenator, Cardiopulmonary Bypass · 300d
Cleared Dec 11, 2001
DATEX-OHMEDA S/5 NETWORK AND CENTRAL '01
K013246 · Datex-Ohmeda
MSX · System, Network And Communication, Physiological Monitors · 74d
Cleared Dec 06, 2001
EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189
K013789 · Boston Scientific, Target
DQY · Catheter, Percutaneous · 22d
Cleared Dec 04, 2001
SELECTIVA GUIDEWIRE
K013024 · Neometrics, Inc.
DQX · Wire, Guide, Catheter · 88d
Cleared Dec 04, 2001
MODIFICATION TO VIKING OPTIMA GUIDING CATHETER
K013638 · Guidant Corp.
DQY · Catheter, Percutaneous · 29d
Cleared Nov 29, 2001
MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A
K013427 · Philips Medical Systems, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 44d
Cleared Nov 28, 2001
PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B
K013199 · Philips Medical Systems, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 64d
Cleared Nov 26, 2001
COMPRESSIBLE LIMB SLEEVE
K011192 · Alliance Medical Corp.
JOW · Sleeve, Limb, Compressible · 221d
Cleared Nov 21, 2001
STENT SUPPORT GUIDE CATHETER
K010579 · Medtronic Vascular
DQY · Catheter, Percutaneous · 267d
Cleared Nov 21, 2001
RENAL GUIDING SHEATH
K012854 · Terumo Medical Corp.
DYB · Introducer, Catheter · 89d
Cleared Nov 21, 2001
CARTO XP EP NAVIGATION SYSTEM
K013083 · Biosense Webster, Inc.
DQK · Computer, Diagnostic, Programmable · 68d
Cleared Nov 21, 2001
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
K013564 · Cambridge Heart, Inc.
DPS · Electrocardiograph · 26d
Cleared Nov 21, 2001
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
K013565 · Cambridge Heart, Inc.
DPS · Electrocardiograph · 26d
Cleared Nov 16, 2001
COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR
K013480 · Cobe Cardiovascular, Inc.
DTZ · Oxygenator, Cardiopulmonary Bypass · 28d
Cleared Nov 15, 2001
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
K012763 · Cobe Cardiovascular, Inc.
DRT · Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · 90d
Cleared Nov 15, 2001
CAPIOX RX HARDSHELL RESERVOIR
K013526 · Terumo Cardiovascular Systems Corp.
DTN · Reservoir, Blood, Cardiopulmonary Bypass · 23d
Cleared Nov 14, 2001
CAROTID GUIDING SHEATH
K012812 · Terumo Medical Corp.
DYB · Introducer, Catheter · 84d
Cleared Nov 14, 2001
MODIFICATION TO M2376A DEVICELINK SYSTEM
K013470 · Philips Medical Systems, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 27d
Cleared Nov 08, 2001
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
K012724 · Smith & Nephew, Inc.
LYK · Angioscope · 86d
Cleared Nov 08, 2001
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS
K013339 · Oscor, Inc.
DTB · Permanent Pacemaker Electrode · 30d
Cleared Nov 02, 2001
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX
K012531 · Datex-Ohmeda
MSX · System, Network And Communication, Physiological Monitors · 88d
Cleared Nov 02, 2001
MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B
K013326 · Datascope Corp.
DSP · System, Balloon, Intra-aortic And Control · 28d
Cleared Nov 01, 2001
ADC 656 ELECTRONIC STETHOSCOPE
K012304 · American Diagnostic Corp.
DQD · Stethoscope, Electronic · 104d
Cleared Oct 31, 2001
MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT
K011761 · Arrow Intl., Inc.
DYB · Introducer, Catheter · 147d

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All categories 14967 DXN System, Measurement, Blood-pressure, Non-invasive 939 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