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
8151–8175 of 14967
Cleared Oct 30, 2001
TM2000 EASYTRACE PLUS RECEIVING CENTER
K013175 · Card Guard Scientific Survival , Ltd.
DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 36d
Cleared Oct 26, 2001
STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE
K001509 · Cobe Cardiovascular, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 529d
Cleared Oct 26, 2001
GORE-TEX VASCULAR GRAFT
K013250 · W.L. Gore & Associates, Inc.
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 28d
Cleared Oct 25, 2001
VENODYNE DVT ADVANTAGE PLUS
K011318 · Microtek Medical, Inc.
JOW · Sleeve, Limb, Compressible · 177d
Cleared Oct 24, 2001
ARROW-TREROTOLA PERCUTANEOUS THROMBOLYTIC DEVICE OR PTD
K011056 · Arrow Intl., Inc.
QEW · Peripheral Mechanical Thrombectomy With Aspiration · 201d
Cleared Oct 23, 2001
MODIFICATION TO: HL168W TOUCH SCREEN
K013033 · Health & Life Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 43d
Cleared Oct 23, 2001
MODIFICATION TO BRAIDED GUIDING INTRODUCER
K013202 · Thomas Medical Products, Inc.
DYB · Introducer, Catheter · 28d
Cleared Oct 18, 2001
STERILMED INTERMITTENT COMPRESSION SYSTEM, GARMENT MODELS 400 SERIES
K003857 · Sterilmed, Inc.
JOW · Sleeve, Limb, Compressible · 309d
Cleared Oct 17, 2001
VANGUARD REPROCESSED COMPRESSION GARMENT
K012403 · Vanguard Medical Concepts, Inc.
JOW · Sleeve, Limb, Compressible · 79d
Cleared Oct 12, 2001
ALTERNANAS PROCESSING SYSTEM, CH 2000 CARDIAC DIAGNOSTIC SYSTEM, HEARTWAVE ALTERNANS PROCESSING SYSTEM
K012206 · Cambridge Heart, Inc.
DQK · Computer, Diagnostic, Programmable · 91d
Cleared Oct 12, 2001
K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
K012404 · Katecho, Inc.
DRO · Pacemaker, Cardiac, External Transcutaneous (non-invasive) · 74d
Cleared Oct 09, 2001
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031
K010954 · Concentric Medical, Inc.
DQY · Catheter, Percutaneous · 193d
Cleared Oct 09, 2001
SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515
K013029 · St Jude Medical
DYB · Introducer, Catheter · 29d
Cleared Oct 04, 2001
MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM
K012950 · Medrad, Inc.
DXT · Injector And Syringe, Angiographic · 30d
Cleared Oct 03, 2001
MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500
K012336 · Medical Data Electronics
DSI · Detector And Alarm, Arrhythmia · 71d
Cleared Sep 28, 2001
VYGON SPLIT CANNULA INTRODUCER
K010913 · Vygon Corp.
DYB · Introducer, Catheter · 185d
Cleared Sep 28, 2001
BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER
K012913 · C.R. Bard, Inc.
DQY · Catheter, Percutaneous · 29d
Cleared Sep 27, 2001
AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T
K013084 · Medtronic Perfusion Systems
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 13d
Cleared Sep 25, 2001
ULTRAFLEX EV HEMOSTASIS INTRODUCER
K012922 · St Jude Medical
DYB · Introducer, Catheter · 25d
Cleared Sep 24, 2001
PORTABLE INTENSIVE CARE UNIT
K012030 · Medical Research Laboratories, Inc.
MKJ · Automated External Defibrillators (non-wearable) · 88d
Cleared Sep 20, 2001
PRECLUDE PERICARDIAL MEMBRANE
K012098 · W.L. Gore & Associates, Inc.
DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · 77d
Cleared Sep 17, 2001
MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
K012898 · Cobe Cardiovascular, Inc.
DTR · Heat-exchanger, Cardiopulmonary Bypass · 19d
Cleared Sep 14, 2001
TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T
K012743 · Medtronic Perfusion Systems
DRY · Monitor, Blood-gas, On-line, Cardiopulmonary Bypass · 29d
Cleared Sep 14, 2001
TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P)
K012747 · Medtronic Perfusion Systems
DPT · Probe, Blood-flow, Extravascular · 29d
Cleared Sep 14, 2001
MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
K012837 · Datex-Ohmeda
MLD · Monitor, St Segment With Alarm · 22d

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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