FDA 510(k) Cardiovascular Devices
About Cardiovascular Devices
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.
18004
Total
17953
Cleared
125d
Avg days
1976
Since
1055 Cardiovascular devices
Cleared
May 07, 2024
ASSURE Wearable ECG
MWJ
Electrocardiograph, Ambulatory (without Analysis)
153d
Cleared
May 03, 2024
Masimo Stork
QYU
Infant Pulse Rate And Oxygen Saturation Monitor For Over-the-counter Use
135d
Cleared
May 02, 2024
Siege Vascular Plug (SVP2.5-0.021)
KRD
Device, Vascular, For Promoting Embolization
92d
Cleared
May 02, 2024
CSF-4 (CSF-4)
DPS
Electrocardiograph
262d
Cleared
May 01, 2024
HOTWIRE™ RF Guidewire
DXF
Catheter, Septostomy
30d
Cleared
May 01, 2024
AuST Steerable Sheath
DYB
Introducer, Catheter
36d
Cleared
Apr 30, 2024
LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021)
DSA
Cable, Transducer And Electrode, Patient, (including Connector)
102d
Cleared
Apr 29, 2024
XTRA Autotransfusion System (with XTRA Bowl sets)
CAC
Apparatus, Autotransfusion
59d
Cleared
Apr 29, 2024
Blood Pressure Monitor (TMB-2287-B)
DXN
System, Measurement, Blood-pressure, Non-invasive
104d
Cleared
Apr 26, 2024
TME Temporary Myocardial Electrode
LDF
Electrode, Pacemaker, Temporary
270d
Cleared
Apr 25, 2024
CDI OneView Monitoring System
DRY
Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
125d
Cleared
Apr 25, 2024
Portrait VSM
MWI
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
147d
Cleared
Apr 23, 2024
Provisio™ SLT IVUS™ System
OBJ
Catheter, Ultrasound, Intravascular
131d
Cleared
Apr 22, 2024
Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA)
DXN
System, Measurement, Blood-pressure, Non-invasive
123d
Cleared
Apr 19, 2024
Bio-Medicus Life Support Catheter and Introducer
QHW
Single Lumen Ecmo Cannula
53d
Cleared
Apr 19, 2024
LIFEPAK® 35 AC Power Adapter (41335-000001)
MPD
Auxiliary Power Supply (ac Or Dc) For Low-energy Dc-defibrillator
88d
Cleared
Apr 19, 2024
ICE Aspiration System
QEW
Peripheral Mechanical Thrombectomy With Aspiration
119d
Cleared
Apr 19, 2024
Patient Monitor (iX10, iX12, iX15)
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
211d
Cleared
Apr 18, 2024
HotDog Warming Mattress + Return Electrode
DWJ
System, Thermal Regulating
233d
Cleared
Apr 15, 2024
Novalung ultimate kit (US)
QJZ
Extracorporeal System For Long-term Respiratory / Cardiopulmonary Failure
208d
Cleared
Apr 10, 2024
Keikku Electronic stethoscope
DQD
Stethoscope, Electronic
194d
Cleared
Apr 09, 2024
TransForm McCarthy Mitral Annuloplasty Ring (TF)
KRH
Ring, Annuloplasty
225d
Cleared
Apr 05, 2024
CorVista System with PH Add-On
SAT
Pulmonary Hypertension Machine Learning-based Notification Software
142d
Cleared
Apr 05, 2024
APPRAISE-HRI
SAR
Adjunctive Hemodynamic Indicator With Decision Point For Military Use
190d
Cleared
Apr 05, 2024
MCG-S (AM1000)
DPS
Electrocardiograph
205d
Looking for a specific cardiovascular device? Search by device name, K-number or manufacturer.
Search all Cardiovascular 510(k) devices