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
14964 Cardiovascular devices
8051–8075 of 14964
Cleared Apr 04, 2002
SARNS CENTRIFUGAL PUMP WITH XCOATING, MODEL 164275X
K020998 · Terumo Cardiovascular Systems Corp.
KFM · Pump, Blood, Cardiopulmonary Bypass, Non-roller Type · 7d
Cleared Apr 03, 2002
SAFE-STEER GUIDE WIRE SYSTEM
K011986 · Intra Luminal Therapeutics, Inc.
DQX · Wire, Guide, Catheter · 281d
Cleared Apr 03, 2002
ADVANTA SST BIFURCATED GRAFT
K020767 · Atrium Medical Corp.
DSY · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter · 26d
Cleared Mar 28, 2002
PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB
K020669 · Oscor, Inc.
DTB · Permanent Pacemaker Electrode · 27d
Cleared Mar 27, 2002
PROWLER SELECT 10 AND 14 INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
K020680 · Cordis Neurovascular, Inc.
KRA · Catheter, Continuous Flush · 23d
Cleared Mar 25, 2002
ZOLL PAD
K011388 · Zoll Medical Corp
MKJ · Automated External Defibrillators (non-wearable) · 322d
Cleared Mar 21, 2002
DINAMAP PRO 1000 MONITOR, MODEL 1000
K012915 · Ge Medical Systems Information Technologies
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 203d
Cleared Mar 20, 2002
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR
K020316 · Cordis Corp.
DQO · Catheter, Intravascular, Diagnostic · 49d
Cleared Mar 20, 2002
PATIENTNET MONITORING SYSTEM
K020524 · General Electric Medical Systems Information Techn
MSX · System, Network And Communication, Physiological Monitors · 29d
Cleared Mar 20, 2002
PHILIPS MULTI-PARAMETER MODULE, MODEL M3001A
K020531 · Philips Medical Systems
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 29d
Cleared Mar 19, 2002
ANGIO FLOW THERMODILUTION CATHETER, MODEL AF-CATH-01
K010253 · Transonic Systems, Inc.
DYG · Catheter, Flow Directed · 417d
Cleared Mar 15, 2002
ENGUARD REMOTE PATIENT MONITOR
K020632 · Mennen Medical , Ltd.
QYX · Outpatient Cardiac Telemetry · 16d
Cleared Mar 14, 2002
CHASE CARDIOVASCULAR PATCH KIT
K020233 · Chase Medical, Inc.
DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · 50d
Cleared Mar 13, 2002
ACIST 4 FRENCH ANGIOGRAPHIC CATHETER
K012983 · Acist Medical Systems, Inc.
DQO · Catheter, Intravascular, Diagnostic · 189d
Cleared Mar 12, 2002
IN-TIME RETRIEVAL DEVICE
K014109 · Boston Scientific, Target
MMX · Device, Percutaneous Retrieval · 88d
Cleared Mar 08, 2002
EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL
K014052 · Edwards Lifesciences, LLC
DYB · Introducer, Catheter · 88d
Cleared Mar 08, 2002
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL
K014054 · Edwards Lifesciences, LLC
DQO · Catheter, Intravascular, Diagnostic · 88d
Cleared Mar 07, 2002
BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
K014075 · Baylis Medical Co., Inc.
DQX · Wire, Guide, Catheter · 86d
Cleared Mar 05, 2002
ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822
K014204 · K-Jump Health Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 74d
Cleared Mar 01, 2002
MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING
K020340 · Guidant Corp.
DQX · Wire, Guide, Catheter · 28d
Cleared Feb 28, 2002
MODEL 9210 DELIVERY CATHETER, MODEL 9210
K013963 · Medtronic Vascular
DQY · Catheter, Percutaneous · 87d
Cleared Feb 26, 2002
CHASE CARDIOVASCULAR PATCH KIT
K020132 · Chase Medical, Inc.
DXZ · Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene · 42d
Cleared Feb 26, 2002
D 903 AVANT 2 PH.I.S.I.O. ADULT HOLLOW FIBER OXYGENATOR
K020351 · Dideco S.P.A.
DTZ · Oxygenator, Cardiopulmonary Bypass · 22d
Cleared Feb 22, 2002
AGILTRAC .018 PERIPHERAL DILATATION CATHETER
K020161 · Guidant Corp.
DQY · Catheter, Percutaneous · 36d
Cleared Feb 21, 2002
MODIFICATION TO M2376A DEVICELINK SYSTEM
K020494 · Philips Medical Systems, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 8d

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All categories 14964 DXN System, Measurement, Blood-pressure, Non-invasive 939 DQY Catheter, Percutaneous 792 DQX Wire, Guide, Catheter 701 DYB Introducer, Catheter 638 DPS Electrocardiograph 443 DTB Permanent Pacemaker Electrode 424 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 413 DQO Catheter, Intravascular, Diagnostic 404 DXY Implantable Pacemaker Pulse-generator 393 DQK Computer, Diagnostic, Programmable 377 LIT Catheter, Angioplasty, Peripheral, Transluminal 365 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 339 DSI Detector And Alarm, Arrhythmia 310 JOW Sleeve, Limb, Compressible 288 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 275