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

15138 Cardiovascular devices

11851–11875 of 15138

Cleared Jan 12, 1989

K884451 · Huntleigh Technology, Inc.

JOM · Plethysmograph, Photoelectric, Pneumatic Or Hydraulic · 80d

Cleared Jan 12, 1989

USCI ADJUSTABLE TIP GUIDE WIRE

K884647 · C.R. Bard, Inc.

DQX · Wire, Guide, Catheter · 66d

Cleared Jan 12, 1989

FUKUDA DENSHI MODEL FX-1201

K884992 · Fukuda Denshi USA, Inc.

DPS · Electrocardiograph · 42d

Cleared Jan 12, 1989

MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR

K885101 · Medtronic Vascular

DSA · Cable, Transducer And Electrode, Patient, (including Connector) · 31d

Cleared Jan 12, 1989

MODIFIED LABEL CHANGE TO MODEL 5455 SURGICAL CABLE

K885171 · Andover Medical, Inc.

DRO · Pacemaker, Cardiac, External Transcutaneous (non-invasive) · 30d

Cleared Jan 11, 1989

TRANSLUMBAR AORTOGRAPHY NEEDLE CATHETER

K884375 · Argon Medical Corp.

DQR · Cannula, Catheter · 85d

Cleared Jan 10, 1989

ANGIOPUMP TUBING SET

K884310 · Olympus Corp.

DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 89d

Cleared Jan 10, 1989

MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER

K884331 · Medtronic Vascular

DTC · Analyzer, Pacemaker Generator Function · 88d

Cleared Jan 10, 1989

EDENTEC MODEL 4700 SCANNER

K884388 · Edentec Corp.

DSF · Recorder, Paper Chart · 84d

Cleared Jan 05, 1989

MODEL 463 ELECTROCARDIORECORDER RECORDER

K884330 · Del Mar Avionics

DSH · Recorder, Magnetic Tape, Medical · 83d

Cleared Dec 28, 1988

EDENTRACE MULTI-CHARTER MODEL 3700

K883315 · Edentec Corp.

DSF · Recorder, Paper Chart · 145d

Cleared Dec 28, 1988

LIFEPAK 50 MONITOR/DEFIBRILLATOR

K883617 · Physio-Control Corp.

LDD · Dc-defibrillator, Low-energy, (including Paddles) · 126d

Cleared Dec 28, 1988

CARDIOCAP(TM) CM-104 MONITOR

K884955 · Datex Division Instrumentarium Corp.

DXN · System, Measurement, Blood-pressure, Non-invasive · 29d

Cleared Dec 27, 1988

ECG/RESPIRATION/ARRHYTHMIA MODULE FOR RM-301

K880505 · Ppg Industries, Inc.

DSI · Detector And Alarm, Arrhythmia · 326d

Cleared Dec 27, 1988

Q5000 ST/HR SLOPE MODIFICATION

K883468 · Quinton, Inc.

DPS · Electrocardiograph · 134d

Cleared Dec 27, 1988

SURGICAL CLAMP INSERTS

K883790 · Applied Vascular Devices, Inc.

DXC · Clamp, Vascular · 111d

Cleared Dec 27, 1988

SURGICAL SPRING CLIPS

K883909 · Applied Vascular Devices, Inc.

DSS · Clip, Vascular · 103d

Cleared Dec 27, 1988

BUCHBINDER MULTIFLEX GUIDEWIRE

K884274 · Medtronic Vascular

DQX · Wire, Guide, Catheter · 76d

Cleared Dec 27, 1988

MODIFIED SHILEY FEMORAL ARTERIAL CANNULA

K884393 · Shiley, Inc.

DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 77d

Cleared Dec 27, 1988

CARDIOCAP(TM) CTO-104 MONITOR

K884956 · Datex Division Instrumentarium Corp.

DPS · Electrocardiograph · 28d

Cleared Dec 21, 1988

USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR

K884104 · C.R. Bard, Inc.

DYB · Introducer, Catheter · 83d

Cleared Dec 21, 1988

ACS(R) HI-TORQUE GOLD(TM) GUIDE WIRE

K884262 · Advanced Cardiovascular Systems, Inc.

DQX · Wire, Guide, Catheter · 71d

Cleared Dec 16, 1988

MRL PACETTE, 450SLL

K880932 · Medical Research Laboratories, Inc.

DRO · Pacemaker, Cardiac, External Transcutaneous (non-invasive) · 284d

Cleared Dec 16, 1988

OXINET N-7500 PULSE OXIMETRY NETWORK

K884142 · Nellcor, Inc.

DXH · Transmitters And Receivers, Electrocardiograph, Telephone · 77d

Cleared Dec 15, 1988

IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436

K884278 · Telectronics, Inc.

DTB · Permanent Pacemaker Electrode · 64d

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