FDA Review Panel · CV

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
1058 Cardiovascular devices
901–925 of 1058
Cleared Aug 04, 2022
Mini-ClotTriever Thrombectomy System
K220887 · Inari Medical
QEW · Peripheral Mechanical Thrombectomy With Aspiration · 129d
Cleared Jul 27, 2022
BIOMONITOR IIIm, BIOMONITOR III
K221856 · Biotronik, Inc.
MXD · Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) · 30d
Cleared Jul 19, 2022
Selectra Lead Implantation System
K222037 · Biotronik, Inc.
DQY · Catheter, Percutaneous · 8d
Cleared Jul 12, 2022
Protrieve Sheath
K220415 · Inari Medical, Inc.
QEW · Peripheral Mechanical Thrombectomy With Aspiration · 148d
Cleared Jul 12, 2022
N Series Patient Monitors
K213799 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
MHX · Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) · 218d
Cleared Jul 11, 2022
Artix Ballon Guiding Sheath
K221846 · Inari Medical
DQY · Catheter, Percutaneous · 17d
Cleared Jul 06, 2022
Oscar Peripheral Multifunctional Catheter system
K214038 · Biotronik, Inc.
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 195d
Cleared Jul 01, 2022
AcQMap High Resolution Imaging and Mapping System
K220784 · Acutus Medical, Inc.
DQK · Computer, Diagnostic, Programmable · 106d
Cleared Jul 01, 2022
CROSSLEAD Peripheral Guide Wire
K213315 · Asahi Intecc Co., Ltd.
DQX · Wire, Guide, Catheter · 270d
Cleared Jun 30, 2022
CPS AIM Universal II Slittable Inner Catheter
K221750 · Abbott Medical
DQY · Catheter, Percutaneous · 14d
Cleared Jun 30, 2022
NC TREK NEO Coronary Dilatation Catheter
K220634 · Abbott Vascular
LOX · Catheters, Transluminal Coronary Angioplasty, Percutaneous · 118d
Cleared Jun 30, 2022
Epicardial Access System
K213582 · Baylis Medical Company, Inc.
DYB · Introducer, Catheter · 230d
Cleared Jun 28, 2022
VenAir, Sequential Compression System
K213577 · Apex Medical Corp.
JOW · Sleeve, Limb, Compressible · 230d
Cleared Jun 22, 2022
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote
K213682 · Edwards Lifesciences, LLC
DQK · Computer, Diagnostic, Programmable · 212d
Cleared Jun 21, 2022
Aspirex Thrombectomy System
K220270 · C.R. Bard, Inc.
QEW · Peripheral Mechanical Thrombectomy With Aspiration · 141d
Cleared Jun 21, 2022
AcQMap 3D Imaging and Mapping Catheter, Model 900009
K210766 · Acutus Medical, Inc.
MTD · Catheter, Intracardiac Mapping, High-density Array · 463d
Cleared Jun 10, 2022
IntellaMap Orion High Resolution Mapping Catheter
K220796 · Boston Scientific Corporation
DRF · Catheter, Electrode Recording, Or Probe, Electrode Recording · 84d
Cleared Jun 07, 2022
Infinity Gateway Suite
K203579 · Draeger Medical Systems, Inc.
MSX · System, Network And Communication, Physiological Monitors · 547d
Cleared Jun 01, 2022
BeneVision Central Monitoring System
K220058 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
MSX · System, Network And Communication, Physiological Monitors · 146d
Cleared May 31, 2022
Liverty™ TIPS Access Set
K221440 · Bard Peripheral Vascular, Inc.
DYB · Introducer, Catheter · 14d
Cleared May 25, 2022
Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter
K210655 · Innovative Health, LLC
OWQ · Reprocessed Intravascular Ultrasound Catheter · 447d
Cleared May 23, 2022
Triever24, Triever20
K213402 · Inari Medical
QEW · Peripheral Mechanical Thrombectomy With Aspiration · 217d
Cleared May 09, 2022
VersaCross Connect Transseptal Dilator
K220414 · Baylis Medical Company, Inc.
DYB · Introducer, Catheter · 84d
Cleared May 05, 2022
Viatrac 14 Plus Peripheral Dilatation Catheter
K221057 · Abbott Vascular
LIT · Catheter, Angioplasty, Peripheral, Transluminal · 24d
Cleared May 05, 2022
AcQGuide® VUE Steerable Sheath
K221044 · Acutus Medical, Inc.
DRA · Catheter, Steerable · 27d

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

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All categories 1058 DXN System, Measurement, Blood-pressure, Non-invasive 84 DQK Computer, Diagnostic, Programmable 73 DYB Introducer, Catheter 68 QEW Peripheral Mechanical Thrombectomy With Aspiration 62 DQY Catheter, Percutaneous 60 MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) 39 DQX Wire, Guide, Catheter 37 DPS Electrocardiograph 24 MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) 21 JOW Sleeve, Limb, Compressible 19 OBJ Catheter, Ultrasound, Intravascular 19 KRD Device, Vascular, For Promoting Embolization 18 MXD Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) 17 DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 17 LIT Catheter, Angioplasty, Peripheral, Transluminal 15