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
8101–8125 of 14964
Cleared Jan 17, 2002
ROSSMAX MEDIPRO, MODELS 100F, 200F, AND 300F BLOOD PRESSURE MONITORS
K013539 · Rossmax International , Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 85d
Cleared Jan 17, 2002
ROSSMAX MEDIPRO MODEL 10 AND 60, MEDICARE MODEL 10 AND 60 BLOOD PRESSURE MONITORS
K013583 · Rossmax International , Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 79d
Cleared Jan 17, 2002
HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
K014157 · Philips Medical Systems
MKJ · Automated External Defibrillators (non-wearable) · 29d
Cleared Jan 17, 2002
BARD CONQUEST PTA BALLOON DILATATION CATHETER
K014212 · C.R. Bard, Inc.
DQY · Catheter, Percutaneous · 27d
Cleared Jan 17, 2002
SIEMENS INFINITY GATEWAY SUITE
K014213 · Siemens Medical Solutions USA, Inc.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 27d
Cleared Jan 16, 2002
HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096
K013833 · Guidant Corp.
DQX · Wire, Guide, Catheter · 58d
Cleared Jan 16, 2002
HL168E
K014122 · Health & Life Co., Ltd.
DXN · System, Measurement, Blood-pressure, Non-invasive · 30d
Cleared Jan 16, 2002
NUMED COEFFICIENT PTV CATHETERS
K014124 · NuMED, Inc.
OMZ · Pulmonary (pulmonic) Valvuloplasty Catheters/percutaneous Valvuloplasty Catheter · 30d
Cleared Jan 15, 2002
SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)
K014161 · St. Jude Medical, Inc.
KRH · Ring, Annuloplasty · 27d
Cleared Jan 15, 2002
M2376A DEVICELINK SYSTEM, MODEL M2376A
K014181 · Philips Medical Systems, Inc.
MWI · Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) · 26d
Cleared Jan 14, 2002
HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A
K013425 · Philips Medical Systems
MKJ · Automated External Defibrillators (non-wearable) · 90d
Cleared Jan 11, 2002
REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES
K013598 · C.R. Bard, Inc.
DSA · Cable, Transducer And Electrode, Patient, (including Connector) · 72d
Cleared Jan 11, 2002
MODIFICATION TO SUPERCROSS CATHETER
K014118 · Abbott Vascular, Inc.
DQY · Catheter, Percutaneous · 28d
Cleared Jan 11, 2002
WARMTOUCH CARDIAC BLANKET,CATALOG # 503-0860
K014121 · Nellcor Puritan Bennett, Inc.
DWJ · System, Thermal Regulating · 25d
Cleared Jan 10, 2002
INFINITY EXPLORER
K013515 · Siemens Medical Solutions USA, Inc.
DXJ · Display, Cathode-ray Tube, Medical · 80d
Cleared Jan 10, 2002
MAC 5000 ECG ANALYSIS SYSTEM
K014108 · General Electric Medical Systems Information Techn
DQK · Computer, Diagnostic, Programmable · 28d
Cleared Jan 08, 2002
DATEX-OHMEDA S/5 WEB VIEWER
K013387 · Datex-Ohmeda
MSX · System, Network And Communication, Physiological Monitors · 88d
Cleared Jan 08, 2002
APEX ADULT HOLLOWE FIBER OXYGENATOR
K014080 · Dideco S.P.A.
DTZ · Oxygenator, Cardiopulmonary Bypass · 28d
Cleared Jan 04, 2002
SJM SEGUIN ANNULOPLASTY RING (SEGUIN RING), MODEL SARP-(SIZE)
K014037 · St. Jude Medical, Inc.
KRH · Ring, Annuloplasty · 28d
Cleared Jan 03, 2002
NUMED MULLINS PTA CATHETER
K013601 · NuMED, Inc.
DQY · Catheter, Percutaneous · 64d
Cleared Dec 27, 2001
D902 PH.I.S.I.O OXYGENATOR
K013915 · Dideco S.P.A.
DTZ · Oxygenator, Cardiopulmonary Bypass · 30d
Cleared Dec 21, 2001
VANGUARD REPROCESSED FEMORAL COMPRESSION DEVICE
K011832 · Vanguard Medical Concepts, Inc.
NMF · Clamp, Vascular, Reprocessed · 192d
Cleared Dec 21, 2001
ULTRA -THIN SDS BALLOON DILATATION CATHETER
K011889 · Boston Scientific Corp
DQY · Catheter, Percutaneous · 186d
Cleared Dec 18, 2001
RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720
K013943 · Radi Medical Systems AB
DSK · Computer, Blood-pressure · 19d
Cleared Dec 13, 2001
HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K013092 · Guidant Corp.
DQX · Wire, Guide, Catheter · 87d

Looking for a specific cardiovascular device? Search by device name, K-number or manufacturer.

Search all Cardiovascular 510(k) devices

Filter by Product Code

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