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

15019 Cardiovascular devices

9276–9300 of 15019

Cleared Dec 19, 1997

RADIAL AND FEMORAL ARTERY CATHETER

K971086 · B.Braun Medical, Inc.

DQX · Wire, Guide, Catheter · 269d

Cleared Dec 19, 1997

TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL

K973708 · Merit Medical Systems, Inc.

DQX · Wire, Guide, Catheter · 81d

Cleared Dec 19, 1997

ELECTRODE, ELECTROCARDIOGRAPH

K973727 · Don Tay Industries

DRX · Electrode, Electrocardiograph · 80d

Cleared Dec 17, 1997

THERMO-STAT SYSTEM

K970367 · Aquarius Medical Corp.

DWJ · System, Thermal Regulating · 320d

Cleared Dec 17, 1997

VASOCOR PVR 100

K973659 · Vasocor, Inc.

JOM · Plethysmograph, Photoelectric, Pneumatic Or Hydraulic · 83d

Cleared Dec 16, 1997

T-REX BIOPSY FORCEPS

K973818 · Boston Scientific Corp

DWZ · Device, Biopsy, Endomyocardial · 70d

Cleared Dec 16, 1997

HEARTPORT ENDOAORTIC CLAMP CATHETER

K974175 · Heartport, Inc.

DWZ · Device, Biopsy, Endomyocardial · 40d

Cleared Dec 12, 1997

HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG

K973494 · Guidant Corp.

DQX · Wire, Guide, Catheter · 88d

Cleared Dec 11, 1997

FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX

K964663 · Rmds, Inc.

DXC · Clamp, Vascular · 385d

Cleared Dec 11, 1997

IVT 0.014 PTFE-COATED TRACKWIRE

K971688 · Boston Scientific /International Technologies

DQX · Wire, Guide, Catheter · 218d

Cleared Dec 11, 1997

COURIER ST BALLOON DILATATION CATHETER

K972744 · Boston Scientific Corp

LIT · Catheter, Angioplasty, Peripheral, Transluminal · 141d

Cleared Dec 09, 1997

HEART PROTECTOR (VER 1996)

K965158 · N.P.N.T., Inc.

DRT · Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · 351d

Cleared Dec 08, 1997

COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR

K963518 · Cobe Cardiovascular, Inc.

DTZ · Oxygenator, Cardiopulmonary Bypass · 461d

Cleared Dec 08, 1997

3M CDI H/S CUVETTES WITH HEPARON TREATMENT

K973472 · 3M Healthcare

DRY · Monitor, Blood-gas, On-line, Cardiopulmonary Bypass · 87d

Cleared Dec 05, 1997

ACIST ANGIOGRAPHIC INJECTOR

K963982 · Invasatec

DXT · Injector And Syringe, Angiographic · 429d

Cleared Dec 04, 1997

K971650 · Data Critical Corp.

DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 212d

Cleared Dec 04, 1997

CARDIOCALL CARDIAC EVENT RECORDER

K972649 · Reynolds Medical , Ltd.

DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 142d

Cleared Dec 03, 1997

HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES

K973437 · Hewlett-Packard GmbH

DPS · Electrocardiograph · 84d

Cleared Dec 02, 1997

FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH

K971440 · Fukuda Denshi USA, Inc.

Cleared Nov 25, 1997

FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T)

K973216 · Rmds, Inc.

DXC · Clamp, Vascular · 90d

Cleared Nov 25, 1997

MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)

K973230 · Merit Medical Systems, Inc.

DXT · Injector And Syringe, Angiographic · 90d

Cleared Nov 24, 1997

FLUORO-TEX SURGICAL MEMBRANE

K973178 · Bridger Biomed, Inc.

DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · 91d

Cleared Nov 24, 1997

CERTODYN RAECG UNIVERSAL ADAPTER

K973371 · B.Braun Medical, Inc.

DQY · Catheter, Percutaneous · 77d

Cleared Nov 20, 1997

CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES)

K973475 · Medtronic Vascular

DTR · Heat-exchanger, Cardiopulmonary Bypass · 69d

Cleared Nov 19, 1997

BLUE MAX - 20 BALLOON DILATATION CATHETER

K972357 · Boston Scientific Corp

LIT · Catheter, Angioplasty, Peripheral, Transluminal · 147d

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