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FDA 510(k)

VASOBand Vascular Compression Device

K-Number: K190318 · 2019-03-14

ApplicantVasoinnovations, Inc.
Decision Date2019-03-14
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VASOBand Vascular Compression Device is a medical device manufactured by Vasoinnovations, Inc.. It received FDA 510(k) clearance on 2019-03-14 under approval number K190318. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASOBand Vascular Compression Device?

VASOBand Vascular Compression Device is a medical device that received FDA 510(k) clearance on 2019-03-14. It is manufactured by Vasoinnovations, Inc.. The 510(k) number is K190318.

When was VASOBand Vascular Compression Device approved by the FDA?

VASOBand Vascular Compression Device received FDA 510(k) clearance on 2019-03-14, under approval number K190318.

What company makes VASOBand Vascular Compression Device?

VASOBand Vascular Compression Device is manufactured by Vasoinnovations, Inc..

What is the FDA product code for VASOBand Vascular Compression Device?

The FDA product code for VASOBand Vascular Compression Device is DXC.

Related Clinical Trials

NCT07613931 Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment NOT_YET_RECRUITING NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT02890160 A Trial of Firesorb in Patients With Coronary Artery Disease: FUTURE-II COMPLETED NCT07604922 Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease NOT_YET_RECRUITING NCT07603531 Assessment of the Efficacy of the Dynamic Decongestive System in the Maintenance Phase of Lower Limb Lymphedema NOT_YET_RECRUITING NCT07305870 Sequential Compression Device in Distributive Peripheral Edema and Hemodynamic Stability Among Patients in Critical Care Units ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41112966 Vascular Reconstruction Device for Coil Embolization of Wide-Neck Type Cerebral Aneurysm: Findings from a Post-Marketing Surveillance Study in Japan. Journal of neuroendovascular therapy (2025)

Other Devices by Vasoinnovations, Inc.

K203803VASOBand Vascular Compression Device

Related Devices (Code: DXC)

K162027TRAcelet Compression DeviceMedtronic Vascular K161315Vein Clamps, Artery ClampsAros Surgical Instruments Corporation K153259VasoStat Hemostasis DeviceForge Medical, Inc. K170958ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cmTricol Biomedical, Inc. K163693IntraClude Intra-Aortic Occlusion DeviceEdwards Lifesciences, LLC K162988PreludeSYNC Radial Compression DeviceMerit Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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