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
1057 Cardiovascular devices
Cleared
Dec 20, 2022
EK12 V2 Algorithm
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
173d
Cleared
Dec 19, 2022
ViewFlex Xtra Reprocessed ICE Catheter
OWQ
Reprocessed Intravascular Ultrasound Catheter
147d
Cleared
Dec 19, 2022
Mechanical Guidewire
DQX
Wire, Guide, Catheter
223d
Cleared
Dec 02, 2022
Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor
MWI
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
231d
Cleared
Nov 22, 2022
HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)
DQK
Computer, Diagnostic, Programmable
162d
Cleared
Nov 15, 2022
LifeSPARC System
QNR
Blood Pump For Ecmo, Long-term (> 6 Hours) Use
519d
Cleared
Nov 08, 2022
SelectSite C304 Deflectable Catheter System, C315 Delivery System
DQY
Catheter, Percutaneous
28d
Cleared
Nov 07, 2022
Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system
DQY
Catheter, Percutaneous
46d
Cleared
Nov 07, 2022
HemoSphere Advanced Monitor, HemoSphere ClearSight Module
DXN
System, Measurement, Blood-pressure, Non-invasive
137d
Cleared
Oct 28, 2022
Welch Allyn Connex Central Station
MWI
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
448d
Cleared
Oct 18, 2022
MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System
DPS
Electrocardiograph
165d
Cleared
Oct 17, 2022
AcQMap High Resolution Imaging and Mapping System
DQK
Computer, Diagnostic, Programmable
84d
Cleared
Oct 06, 2022
NuCath Wedge Pressure Catheter
DQO
Catheter, Intravascular, Diagnostic
318d
Cleared
Oct 04, 2022
INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)
QEW
Peripheral Mechanical Thrombectomy With Aspiration
210d
Cleared
Sep 28, 2022
MitraClip G4 Steerable Guide Catheter
DRA
Catheter, Steerable
138d
Cleared
Sep 23, 2022
OptiCross™ 18 Peripheral Imaging Catheter
OBJ
Catheter, Ultrasound, Intravascular
30d
Cleared
Sep 06, 2022
ROTAPRO Rotational Atherectomy System
MCW
Catheter, Peripheral, Atherectomy
158d
Cleared
Sep 06, 2022
ASAHI Gladius Mongo18 PV ES
DQX
Wire, Guide, Catheter
270d
Cleared
Aug 25, 2022
LINQ II Insertable Cardiac Monitor
MXD
Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
51d
Cleared
Aug 22, 2022
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
DXF
Catheter, Septostomy
88d
Cleared
Aug 17, 2022
CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)
DQK
Computer, Diagnostic, Programmable
124d
Cleared
Aug 15, 2022
HeRO Graft
DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
249d
Cleared
Aug 11, 2022
Patient Monitor: RespArray
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
190d
Cleared
Aug 06, 2022
Reprocesses Umbilical Cable
NLH
Catheter, Recording, Electrode, Reprocessed
40d
Cleared
Aug 04, 2022
Mini-ClotTriever Thrombectomy System
QEW
Peripheral Mechanical Thrombectomy With Aspiration
129d
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