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
14880 Cardiovascular devices
6501–6525 of 14880
Cleared Aug 03, 2007
UNIRING - ANNULOPLASTY RING WITH SIZERS
K071281 · Peters Surgical
KRH · Ring, Annuloplasty · 88d
Cleared Jul 31, 2007
ANGIOJET XPEEDIOR RHEOLYTIC THROMBECTOMY CATHETER, MODEL 104307
K071514 · Possis Medical, Inc.
QEZ · Aspiration Thrombectomy Catheter · 57d
Cleared Jul 31, 2007
ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040, 105042, 106552, 105043, 105041, 106553, 105039
K071342 · Possis Medical, Inc.
QEZ · Aspiration Thrombectomy Catheter · 78d
Cleared Jul 31, 2007
ATS SIMULUS ADJUSTABLE FLEXIBLE ANNULOPLASTY RING
K071214 · Genesee Biomedical, Inc.
KRH · Ring, Annuloplasty · 91d
Cleared Jul 26, 2007
NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515
K071819 · Ncontact Surgical, Inc.
OCL · Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue · 23d
Cleared Jul 24, 2007
DL900 SERIES HOLTER RECORDER
K071733 · Braemar, Inc.
MWJ · Electrocardiograph, Ambulatory (without Analysis) · 28d
Cleared Jul 23, 2007
CAPIOX FX05 HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER
K071572 · Terumo Corp.
DTZ · Oxygenator, Cardiopulmonary Bypass · 45d
Cleared Jul 18, 2007
SCOUTPRO SLITTER TOOL ADVANCED, MODEL 356 552
K071665 · Biotronik, Inc.
DQY · Catheter, Percutaneous · 30d
Cleared Jul 16, 2007
CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR AND ARTERIAL FILTER
K071494 · Terumo Corp.
DTZ · Oxygenator, Cardiopulmonary Bypass · 47d
Cleared Jul 16, 2007
BIOIMPEDANCE CARDIAC ANALYZING MEASURING SYSTEM, MODEL NICAS 2004 SLIM
K070500 · Ni Medical
DSB · Plethysmograph, Impedance · 145d
Cleared Jul 13, 2007
ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371
K071721 · Asahi Intecc Co., Ltd.
DQX · Wire, Guide, Catheter · 18d
Cleared Jul 13, 2007
TRELLIS-6 PERIPHERAL INFUSION SYSTEM
K071664 · Bacchus Vascular, Inc.
QEY · Mechanical Thrombolysis Catheter · 25d
Cleared Jul 13, 2007
BLUE MAX BALLOON DILATATION CATHETER
K071309 · Boston Scientific Corp
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 65d
Cleared Jul 13, 2007
RAPIDCOOL PATIENT TEMPERATURE MANAGEMENT SYSTEM
K070112 · Medcool, Inc.
DWJ · System, Thermal Regulating · 183d
Cleared Jul 11, 2007
M2 MONITOR
K071725 · Spectrum Medical , Ltd.
DRY · Monitor, Blood-gas, On-line, Cardiopulmonary Bypass · 16d
Cleared Jul 11, 2007
CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15
K071227 · Spectranetics Corp.
PDU · Catheter For Crossing Total Occlusions · 69d
Cleared Jul 10, 2007
HIGHPAK-12
K062331 · Ad Elektronik GmbH
MPD · Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator · 334d
Cleared Jul 06, 2007
MODIFICATION TO: STOCKERT S5 SYSTEM
K071318 · Sorin Group Deutschland GmbH
DTQ · Console, Heart-lung Machine, Cardiopulmonary Bypass · 57d
Cleared Jul 05, 2007
STIFFER COAXIAL MICRO-INTRODUCER KIT
K071574 · Enpath Medical, Inc.
DYB · Introducer, Catheter · 27d
Cleared Jul 05, 2007
ATRICURE BIPOLAR SYSTEM
K043579 · AtriCure, Inc.
OCL · Surgical Device, For Cutting, Coagulation, And/or Ablation Of Tissue, Including Cardiac Tissue · 919d
Cleared Jul 03, 2007
AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014
K071253 · Medtronic Vascular
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 60d
Cleared Jul 02, 2007
MODEL HBP T-105 SERIES, MODEL T-105 AND T-105S
K071645 · Omron Healthcare, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 17d
Cleared Jul 02, 2007
Z6 STIMULATOR
K070743 · St Cardio Technologies, LLC
JOQ · Generator, Pulse, Pacemaker, External Programmable (for Electrophysiological Studies Only) · 108d
Cleared Jun 29, 2007
ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F
K071234 · Siemens Medical Solutions USA, Inc.
OBJ · Catheter, Ultrasound, Intravascular · 57d
Cleared Jun 29, 2007
8FR TURBO BOOSTER, GUIDE CATHETER, 7FR TURBO BOOSTER, MODEL 518-063, 518-043
K071226 · Spectranetics Corp.
PDU · Catheter For Crossing Total Occlusions · 57d

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All categories 14880 DXN System, Measurement, Blood-pressure, Non-invasive 931 DQY Catheter, Percutaneous 788 DQX Wire, Guide, Catheter 699 DYB Introducer, Catheter 633 DPS Electrocardiograph 440 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 411 DQO Catheter, Intravascular, Diagnostic 401 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 376 LIT Catheter, Angioplasty, Peripheral, Transluminal 363 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 336 DSI Detector And Alarm, Arrhythmia 306 JOW Sleeve, Limb, Compressible 281 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 273