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
15160 Cardiovascular devices
12101–12125 of 15160
Cleared Apr 01, 1988
EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR
K880052 · Baxter Healthcare Corp
DTJ · Holder, Heart-valve, Prosthesis · 86d
Cleared Mar 31, 1988
MASCOT STETHOSCOPE PROBE
K874726 · Imex Medical Systems, Inc.
DQD · Stethoscope, Electronic · 134d
Cleared Mar 31, 1988
TAKEDA MEDICAL AUTO. AMBU. BLOOD PRESS. METER/2420
K880079 · A&D Engineering, Inc.
DSK · Computer, Blood-pressure · 80d
Cleared Mar 31, 1988
MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER
K880422 · Cardiac Control Systems, Inc.
DXY · Implantable Pacemaker Pulse-generator · 59d
Cleared Mar 22, 1988
MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
K872126 · Intermedics, Inc.
DTB · Permanent Pacemaker Electrode · 294d
Cleared Mar 22, 1988
CORDIS STEERABLE GUIDEWIRE
K873403 · Cordis Corp.
DQX · Wire, Guide, Catheter · 211d
Cleared Mar 22, 1988
FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR
K875057 · Fukuda Denshi USA, Inc.
DPS · Electrocardiograph · 104d
Cleared Mar 22, 1988
PERCUTANEOUS ARTERIAL/VENOUS CANNULA PLACEMENT KIT
K875353 · Dlp, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 82d
Cleared Mar 22, 1988
MODEL 303D AND 403D ADULT HEART RATE & RESPIRATOR
K880066 · Ivy Biomedical Systems, Inc.
DRT · Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) · 71d
Cleared Mar 22, 1988
CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPUL.
K880103 · Research Medical, Inc.
DWF · Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass · 70d
Cleared Mar 22, 1988
MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR
K880323 · Medtronic Vascular
DSA · Cable, Transducer And Electrode, Patient, (including Connector) · 56d
Cleared Mar 22, 1988
VITAL SYSTEM
K880351 · Pace Tech, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 56d
Cleared Mar 16, 1988
BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZER
K874361 · Biodynamics Corp.
DSB · Plethysmograph, Impedance · 145d
Cleared Mar 09, 1988
MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED)
K880664 · Mortara Instrument, Inc.
DSI · Detector And Alarm, Arrhythmia · 20d
Cleared Mar 07, 1988
TORAY SUPERSELECTIVE GUIDEWIRES, ADDITIONAL TYPES
K874542 · Toray Industries (America), Inc.
DQX · Wire, Guide, Catheter · 125d
Cleared Mar 07, 1988
MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD
K880551 · Intermedics, Inc.
DTB · Permanent Pacemaker Electrode · 27d
Cleared Mar 02, 1988
RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.
K871555 · General Electric Co.
DXK · Echocardiograph · 315d
Cleared Mar 01, 1988
KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM
K870816 · Kontron Instruments, Inc.
DSI · Detector And Alarm, Arrhythmia · 364d
Cleared Feb 29, 1988
OLYMPUS ANGIOSCOPY SHEATH
K873100 · Olympus Corp.
DYB · Introducer, Catheter · 206d
Cleared Feb 29, 1988
SCIMED INFLATION DEVICE, MODEL SM 2000
K875064 · Scimed Life Systems, Inc.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 82d
Cleared Feb 29, 1988
AIR VENT LINE CAT. NO. AVL-36
K875080 · American Omni Medical, Inc.
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 82d
Cleared Feb 29, 1988
AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*
K875090 · United States Surgical, A Division of Tyco Healthc
DXC · Clamp, Vascular · 82d
Cleared Feb 29, 1988
ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE
K875094 · Pall Biomedical Products Co.
KRJ · Filter, Prebypass, Cardiopulmonary Bypass · 81d
Cleared Feb 29, 1988
PALL CARDIOPLEGIA PLUS FILTER W/POSIDYNE MEMBRANE
K875095 · Pall Biomedical Products Co.
JOD · Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass · 81d
Cleared Feb 29, 1988
NON-INVASIVE BLOOD PRESSURE MODULE
K875265 · Ppg Industries, Inc.
DXN · System, Measurement, Blood-pressure, Non-invasive · 69d

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All categories 15160 DXN System, Measurement, Blood-pressure, Non-invasive 961 DQY Catheter, Percutaneous 796 DQX Wire, Guide, Catheter 707 DYB Introducer, Catheter 644 DPS Electrocardiograph 451 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 415 DQO Catheter, Intravascular, Diagnostic 408 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 384 LIT Catheter, Angioplasty, Peripheral, Transluminal 367 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 346 DSI Detector And Alarm, Arrhythmia 313 JOW Sleeve, Limb, Compressible 293 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 281