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
1061 Cardiovascular devices
Cleared
May 09, 2022
VersaCross Connect Transseptal Dilator
DYB
Introducer, Catheter
84d
Cleared
May 05, 2022
Viatrac 14 Plus Peripheral Dilatation Catheter
LIT
Catheter, Angioplasty, Peripheral, Transluminal
24d
Cleared
May 05, 2022
AcQGuide® VUE Steerable Sheath
DRA
Catheter, Steerable
27d
Cleared
May 04, 2022
Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter
DQY
Catheter, Percutaneous
261d
Cleared
Apr 30, 2022
Ultiri Measurement System
DQK
Computer, Diagnostic, Programmable
92d
Cleared
Apr 20, 2022
EKOS+ Endovascular Device
QEY
Mechanical Thrombolysis Catheter
26d
Cleared
Apr 13, 2022
Everest 20 Inflation Device and 3-way Stopcock (AC2200)
MAV
Syringe, Balloon Inflation
28d
Cleared
Apr 13, 2022
CARESCAPE B450, E-musb
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
183d
Cleared
Apr 13, 2022
Carescape B850, E-musb
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
189d
Cleared
Apr 13, 2022
CARESCAPE B650, E-musb
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
196d
Cleared
Apr 12, 2022
EMBOLD Fibered Detachable Coil System
KRD
Device, Vascular, For Promoting Embolization
176d
Cleared
Apr 12, 2022
CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
194d
Cleared
Apr 07, 2022
Electrocardiograph
DPS
Electrocardiograph
261d
Cleared
Apr 04, 2022
AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System
QEZ
Aspiration Thrombectomy Catheter
172d
Cleared
Apr 01, 2022
Aveir Retrieval Catheter
MMX
Device, Percutaneous Retrieval
151d
Cleared
Apr 01, 2022
Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
MHX
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
151d
Cleared
Apr 01, 2022
Intri24 Sheath
DYB
Introducer, Catheter
242d
Cleared
Mar 31, 2022
PhasTIPP
DWQ
Stripper, Vein, External
202d
Cleared
Mar 25, 2022
Artix Thrombectomy Device
QEW
Peripheral Mechanical Thrombectomy With Aspiration
23d
Cleared
Mar 24, 2022
Emerge Monorail PTCA Dilatation Catheter
LOX
Catheters, Transluminal Coronary Angioplasty, Percutaneous
20d
Cleared
Mar 18, 2022
OPTRELL Mapping Catheter with TRUEref Technology
MTD
Catheter, Intracardiac Mapping, High-density Array
312d
Cleared
Mar 10, 2022
Reprocessed Carto Vizigo Bi-Directional Guiding Sheath
PNE
Reprocessed Catheter Introducer
241d
Cleared
Mar 09, 2022
Amplatzer Steerable Delivery Sheath
DQY
Catheter, Percutaneous
30d
Cleared
Mar 01, 2022
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System
MCW
Catheter, Peripheral, Atherectomy
47d
Cleared
Mar 01, 2022
Wrist-type Fully Automatic Digital Blood Pressure Monitor
DXN
System, Measurement, Blood-pressure, Non-invasive
153d
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