CORVASCULAR

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3033275035	3033275035	CORVASCULAR	1	Y	2026-01-01	5810 Baker Rd Ste 125 Minnetonka MN US 55345

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
333593	1619102751	K250791	ASUS Ultrasound Imaging System (LU800 series)	IYN	2025-12-04
333593	1135493648	K233976	VasoGuard (V10, V8, V6, V4, V2)	JOP	2024-07-19
333593	1948485254	K121689	VITASCAN LT SCANMASTER	IYO	2012-09-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
IYN	1	2025-12-04
JOP	1	2024-07-19
IYO	1	2012-09-19

GUDID#

VasoGuard - The VasoGuard devices are intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. The devices are not intended to replace other means of evaluating vital patient physiological testing, are not intended to be used in neonatal applications, and are not intended to be used inside the sterile field. The intended use by qualified and trained medical professionals in hospitals, clinics, and physician offices by prescription or on the order of a medical doctor.VasoGuard Model V6: Medical Grade Touchscreen PC, Windows® Enterprise LTSC; Washable Keyboard with Trackpad; Height-adjustable Rolling Cart
CorVascular
2026-04-08
VasoGuard - The VasoGuard devices are intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. The devices are not intended to replace other means of evaluating vital patient physiological testing, are not intended to be used in neonatal applications, and are not intended to be used inside the sterile field. The intended use by qualified and trained medical professionals in hospitals, clinics, and physician offices by prescription or on the order of a medical doctor.VasoGuard Model V8: Medical Grade Touchscreen PC, Windows® Enterprise LTSC; Washable Keyboard with Trackpad; Height-adjustable Rolling Cart
CorVascular
2026-04-08
VasoGuard - The VasoGuard devices are intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. The devices are not intended to replace other means of evaluating vital patient physiological testing, are not intended to be used in neonatal applications, and are not intended to be used inside the sterile field. The intended use by qualified and trained medical professionals in hospitals, clinics, and physician offices by prescription or on the order of a medical doctor.VasoGuard Model V10: Medical Grade Touchscreen PC, Windows® Enterprise LTSC; Washable Keyboard with Trackpad; Height-adjustable Rolling Cart
CorVascular
2026-04-08
VasoGuard - The VasoGuard devices are intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. The devices are not intended to replace other means of evaluating vital patient physiological testing, are not intended to be used in neonatal applications, and are not intended to be used inside the sterile field. The intended use by qualified and trained medical professionals in hospitals, clinics, and physician offices by prescription or on the order of a medical doctor.VasoGuard Model V2: Medical Grade Touchscreen PC, Windows® Enterprise LTSC; Washable Keyboard with Trackpad; Height-adjustable Rolling Cart
CorVascular
2026-04-08
VasoGuard - The VasoGuard devices are intended for use in the non-invasive evaluation of peripheral vascular pathology in patients. The devices are not intended to replace other means of evaluating vital patient physiological testing, are not intended to be used in neonatal applications, and are not intended to be used inside the sterile field. The intended use by qualified and trained medical professionals in hospitals, clinics, and physician offices by prescription or on the order of a medical doctor.VasoGuard Model V4: Medical Grade Touchscreen PC, Windows® Enterprise LTSC; Washable Keyboard with Trackpad; Height-adjustable Rolling Cart
CorVascular
2026-04-08
VasoGuard - The VasoGuard is a family of products designed for non-invasive peripheral vascular diagnostic testing. It uses Doppler probes and photoplethysmography (PPG) sensors positioned on the body to measure physiologic signals and report data to the interpreting clinician. The system consists of up to 10 independent pneumatic pressure channels,up to five PPG ports, up to three Doppler ports that support 4MHz and 8MHz continuous wave (CW) Doppler probes, and a touchless temperature sensor.Model V2: 2 Pressure Channels / 2 PPG / 0 Doppler
CorVascular
2026-04-08
VasoGuard - The VasoGuard is a family of products designed for non-invasive peripheral vascular diagnostic testing. It uses Doppler probes and photoplethysmography (PPG) sensors positioned on the body to measure physiologic signals and report data to the interpreting clinician. The system consists of up to 10 independent pneumatic pressure channels,up to five PPG ports, up to three Doppler ports that support 4MHz and 8MHz continuous wave (CW) Doppler probes, and a touchless temperature sensor.Model V4: 4 Pressure Channels / 2 PPG / 1 Doppler
CorVascular
2026-04-08
VasoGuard - The VasoGuard is a family of products designed for non-invasive peripheral vascular diagnostic testing. It uses Doppler probes and photoplethysmography (PPG) sensors positioned on the body to measure physiologic signals and report data to the interpreting clinician. The system consists of up to 10 independent pneumatic pressure channels,up to five PPG ports, up to three Doppler ports that support 4MHz and 8MHz continuous wave (CW) Doppler probes, and a touchless temperature sensor.Model V6: 6 Pressure Channels / 4 PPG / 1 Doppler
CorVascular
2026-04-08
VasoGuard - The VasoGuard is a family of products designed for non-invasive peripheral vascular diagnostic testing. It uses Doppler probes and photoplethysmography (PPG) sensors positioned on the body to measure physiologic signals and report data to the interpreting clinician. The system consists of up to 10 independent pneumatic pressure channels,up to five PPG ports, up to three Doppler ports that support 4MHz and 8MHz continuous wave (CW) Doppler probes, and a touchless temperature sensor.Model V8: 8 Pressure Channels / 4 PPG / 2 Doppler
CorVascular
2026-04-08
VasoGuard - The VasoGuard is a family of products designed for non-invasive peripheral vascular diagnostic testing. It uses Doppler probes and photoplethysmography (PPG) sensors positioned on the body to measure physiologic signals and report data to the interpreting clinician. The system consists of up to 10 independent pneumatic pressure channels, up to five PPG ports, up to three Doppler ports that support 4MHz and 8MHz continuous wave (CW) Doppler probes, and a touchless temperature sensor. Model V10: 10 Pressure Channels / 5 PPG / 3 Doppler
CorVascular
2026-04-08