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

15008 Cardiovascular devices

8951–8975 of 15008

Cleared Jan 11, 1999

COBE HVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR

K984456 · Cobe Cardiovascular, Inc.

DTN · Reservoir, Blood, Cardiopulmonary Bypass · 27d

Cleared Jan 08, 1999

K962918 · Lidco, Ltd.

DXG · Computer, Diagnostic, Pre-programmed, Single-function · 925d

Cleared Jan 08, 1999

GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018

K982272 · Biotronik, Inc.

DQX · Wire, Guide, Catheter · 193d

Cleared Jan 07, 1999

MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M

K984435 · Medtronic Vascular

KRH · Ring, Annuloplasty · 27d

Cleared Jan 04, 1999

HEWLETT-PACKARD M1205A VIRIDIA 24 CT

K981376 · Hewlett-Packard Co.

DSI · Detector And Alarm, Arrhythmia · 263d

Cleared Dec 30, 1998

RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003

K983055 · Guidant Corp.

LIT · Catheter, Angioplasty, Peripheral, Transluminal · 120d

Cleared Dec 23, 1998

CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM

K984500 · Cordis Corp.

DYB · Introducer, Catheter · 6d

Cleared Dec 22, 1998

CS/3 COMPACT AIRWAY MODULE, M-COVX

K982091 · Datex-Engstrom, Inc.

MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 190d

Cleared Dec 22, 1998

RADII DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER, MODEL # 30411 B, C AND D

K983653 · Cardiac Pathways Corp.

DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 64d

Cleared Dec 17, 1998

HEARTSTREAM ELECTRODE ADAPTER

K984286 · Hewlett-Packard Co.

MKJ · Automated External Defibrillators (non-wearable) · 16d

Cleared Dec 15, 1998

DISTAFLO BYPASS GRAFT

K983769 · Impra, Inc.

DYF · Prosthesis, Vascular Graft, Of Less Then 6mm Diameter · 50d

Cleared Dec 14, 1998

MS-900S, MS-900SPM & MS-900SFM

K980845 · Mars Medical Products

DXN · System, Measurement, Blood-pressure, Non-invasive · 285d

Cleared Dec 14, 1998

RTM DVT PROSOFT CUFF MODEL NUMBER PS100

K981643 · R.T. Medical Services, Inc.

JOW · Sleeve, Limb, Compressible · 220d

Cleared Dec 11, 1998

SILVERSTREAK HYDROPHILIC GUIDEWIRE

K982543 · Micro Therapeutics, Inc.

DQX · Wire, Guide, Catheter · 143d

Cleared Dec 10, 1998

MEDTRONIC ANGIOGRAPHIC CATHETER

K980973 · Medtronics Interventional Vascular

DQO · Catheter, Intravascular, Diagnostic · 269d

Cleared Dec 09, 1998

K-DEFIB/PACE ADULT ELECTRODE MODEL NUMBER KDP-60

K981737 · Katecho, Inc.

MKJ · Automated External Defibrillators (non-wearable) · 205d

Cleared Dec 03, 1998

MONITOR ONE NDX

K972991 · Qmed, Inc.

DPS · Electrocardiograph · 478d

Cleared Dec 02, 1998

PACEMAKER DATA PMD TRANSMITTER, MODEL CG-4000

K983026 · Card Guard Scientific Survival , Ltd.

DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 93d

Cleared Dec 01, 1998

VENOUS FLEX II PERIPHERAL AND INTRA-OPERATIVE ACCESS VENOUS RETURN CANNULAE

K974259 · Edwards Lifesciences Research Medical

DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 383d

Cleared Dec 01, 1998

PERIPHERAL VASCULAR DILATOR

K974617 · Endovascular Instruments, Inc.

DRE · Dilator, Vessel, For Percutaneous Catheterization · 355d

Cleared Nov 30, 1998

BLUNT T-PEEL INTRODUCER MODEL NUMBER PE-16PICB, PE-18PICB, PE-20PICB, PE-24PICB

K982797 · Luther Medical Products, Inc.

DYB · Introducer, Catheter · 112d

Cleared Nov 25, 1998

ZOLL STAT*PADZ ADULT MULTI-FUNCTION ELECTRODES MODEL NUMBER 8900-4003

K981802 · Bio-Detek, Inc.

MKJ · Automated External Defibrillators (non-wearable) · 188d

Cleared Nov 25, 1998

ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500

K982104 · Medical Data Electronics

MLD · Monitor, St Segment With Alarm · 163d

Cleared Nov 24, 1998

BAXTER HEMOSTASIS VALVE INTRODUCERS

K981909 · Baxter Edwards

DYB · Introducer, Catheter · 176d

Cleared Nov 24, 1998

INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN

K983819 · Intervascular, Inc.

DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 26d

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