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
14797 Cardiovascular devices
5226–5250 of 14797
Cleared Jan 21, 2011
CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3 EPNAVIGATION SYSTEM,VERSION 2.0 W/RMT PAD)
K103746 · Biosense Webster, Inc.
DQK · Computer, Diagnostic, Programmable · 29d
Cleared Jan 20, 2011
SORIN C5 SYSTEM
K103762 · Sorin Group Deutschland GmbH
DTQ · Console, Heart-lung Machine, Cardiopulmonary Bypass · 28d
Cleared Jan 20, 2011
COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE
K103715 · Mirador Biomedical, Inc.
DRS · Transducer, Blood-pressure, Extravascular · 30d
Cleared Jan 20, 2011
STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)
K103468 · Sorin Group Deutschland GmbH
DWA · Control, Pump Speed, Cardiopulmonary Bypass · 57d
Cleared Jan 20, 2011
MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900
K100585 · Gaymar Industries, Inc.
DWJ · System, Thermal Regulating · 324d
Cleared Jan 19, 2011
CPS DIRECT SL II SLITTABLE OUTER CATHETER
K103250 · St. Jude Medical, Cardiac Rhythm Management Divisi
DQY · Catheter, Percutaneous · 77d
Cleared Jan 19, 2011
ALBOGRAFT VASCULAR PROSTHESIS
K103080 · LeMaitre Vascular, Inc.
MAL · Graft, Vascular, Synthetic/biologic Composite · 92d
Cleared Jan 18, 2011
STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05
K103469 · Sorin Group Deutschland GmbH
KRL · Detector, Bubble, Cardiopulmonary Bypass · 55d
Cleared Jan 18, 2011
CARDIO MED
K103334 · Cardio Medical Products, Inc.
LDD · Dc-defibrillator, Low-energy, (including Paddles) · 64d
Cleared Jan 13, 2011
SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8
K103652 · Philips Medical Systesms
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 30d
Cleared Jan 07, 2011
INTELLIVUE MX40 PATIENT MONITOR
K103646 · Phillips Medical Systems
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 24d
Cleared Jan 06, 2011
B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)
K103168 · Sorin Group Deutschland GmbH
DRY · Monitor, Blood-gas, On-line, Cardiopulmonary Bypass · 71d
Cleared Jan 05, 2011
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
K103618 · Ev3, Inc.
MCW · Catheter, Peripheral, Atherectomy · 26d
Cleared Jan 05, 2011
GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE
K103534 · Trireme Medical, Inc.
DQY · Catheter, Percutaneous · 35d
Cleared Jan 04, 2011
INTELLISPHERE EVENT MANAGMENT SYSTEM REL. 10.00
K102974 · Philips Medical Systems
MSX · System, Network And Communication, Physiological Monitors · 90d
Cleared Dec 30, 2010
CANTATA MICROCATHETER
K101450 · Cook, Inc.
KRA · Catheter, Continuous Flush · 220d
Cleared Dec 27, 2010
LIFEBRIDGE
K103357 · Lifebridge Medizintechnik AG
KFM · Pump, Blood, Cardiopulmonary Bypass, Non-roller Type · 41d
Cleared Dec 23, 2010
FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030
K094030 · Cas Medical Systems, Inc.
MUD · Oximeter, Tissue Saturation · 358d
Cleared Dec 22, 2010
PACIFIC XTREME PTCA BALLOON DILATATION CATHETER
K103464 · Medtronic, Inc.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 28d
Cleared Dec 22, 2010
PRONTO V4 EXTRACTION CATHETER 5.5F
K103405 · Vascular Solutions, Inc.
QEZ · Aspiration Thrombectomy Catheter · 33d
Cleared Dec 17, 2010
UNITY NETWORK ID
K103432 · Ge Medical Systems Information Technologies, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 24d
Cleared Dec 17, 2010
REGIONAL OXIMETER
K102715 · Nonin Medical, Inc.
MUD · Oximeter, Tissue Saturation · 88d
Cleared Dec 16, 2010
AVITA WRIST TYPE BLOOD PRESSURE MONITOR
K102624 · Avita Corporation
DXN · System, Measurement, Blood-pressure, Non-invasive · 94d
Cleared Dec 16, 2010
SUPERCROSS MICROCATHETER (130 CM), SUPERCROSS MICROCATHETER (150 CM) MODEL 5300, 5301
K101659 · Vascular Solutions, Inc.
DQY · Catheter, Percutaneous · 188d
Cleared Dec 16, 2010
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
K100646 · Medtronic, Inc.
DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line · 286d

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All categories 14797 DXN System, Measurement, Blood-pressure, Non-invasive 926 DQY Catheter, Percutaneous 786 DQX Wire, Guide, Catheter 698 DYB Introducer, Catheter 627 DPS Electrocardiograph 436 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 409 DQO Catheter, Intravascular, Diagnostic 400 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 375 LIT Catheter, Angioplasty, Peripheral, Transluminal 358 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 336 DSI Detector And Alarm, Arrhythmia 306 JOW Sleeve, Limb, Compressible 273 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 268