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
1056 Cardiovascular devices
Cleared
Jun 27, 2023
EMBOLD™ Soft Detachable Coil System
KRD
Device, Vascular, For Promoting Embolization
105d
Cleared
Jun 23, 2023
GORE® ACUSEAL Vascular Graft
DSY
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
30d
Cleared
Jun 12, 2023
Pounce™ Thrombectomy System
QEW
Peripheral Mechanical Thrombectomy With Aspiration
63d
Cleared
Jun 10, 2023
BMR 1900 PHISIO
DTN
Reservoir, Blood, Cardiopulmonary Bypass
219d
Cleared
Jun 09, 2023
HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor
DQK
Computer, Diagnostic, Programmable
168d
Cleared
Jun 08, 2023
Acumen Hypotension Prediction Index (HPI) Algorithm
QAQ
Adjunctive Predictive Cardiovascular Indicator
150d
Cleared
Jun 08, 2023
AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub
DQK
Computer, Diagnostic, Programmable
161d
Cleared
Jun 06, 2023
Pantheris LV Atherectomy Catheter
MCW
Catheter, Peripheral, Atherectomy
154d
Cleared
Jun 02, 2023
CPS Direct™ Universal slittable outer guide catheter (DS2C029)
DQY
Catheter, Percutaneous
28d
Cleared
Jun 01, 2023
Radius VSM and Accessories
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
192d
Cleared
May 31, 2023
Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
NLH
Catheter, Recording, Electrode, Reprocessed
414d
Cleared
May 26, 2023
WellsForm Tricuspid Annuloplasty Band (WF)
KRH
Ring, Annuloplasty
74d
Cleared
May 25, 2023
Stingray LP Catheter
DQY
Catheter, Percutaneous
30d
Cleared
May 19, 2023
BIOMONITOR IV
MXD
Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)
95d
Cleared
May 19, 2023
Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W
DXN
System, Measurement, Blood-pressure, Non-invasive
233d
Cleared
May 19, 2023
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
KFM
Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
422d
Cleared
May 18, 2023
OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter
OBJ
Catheter, Ultrasound, Intravascular
86d
Cleared
May 17, 2023
Assert-IQ™ Insertable Cardiac Monitor
MXC
Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
104d
Cleared
May 16, 2023
Gunther Tulip Vena Cava Filter Retrieval Set
MMX
Device, Percutaneous Retrieval
293d
Cleared
May 05, 2023
Wattson temporary pacing guidewire (2250)
DQX
Wire, Guide, Catheter
59d
Cleared
May 04, 2023
DLP™ Silicone Coronary Artery Ostial Cannulae
DWF
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
29d
Cleared
May 03, 2023
ViewFlex™ Eco Reprocessed ICE Catheter
OWQ
Reprocessed Intravascular Ultrasound Catheter
30d
Cleared
May 02, 2023
Artix BG
QEW
Peripheral Mechanical Thrombectomy With Aspiration
32d
Cleared
May 02, 2023
AcQMap® High Resolution Imaging and Mapping System
DQK
Computer, Diagnostic, Programmable
60d
Cleared
May 02, 2023
Samsung ECG Monitor Application with Irregular Heart Rhythm Notification
QDA
Electrocardiograph Software For Over-the-counter Use
89d
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