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FDA 510(k)

SiteSeal Femoral Compression Device

K-Number: K192413 · 2020-03-31

ApplicantEnsite Vacular, LLC
Decision Date2020-03-31
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SiteSeal Femoral Compression Device is a medical device manufactured by Ensite Vacular, LLC. It received FDA 510(k) clearance on 2020-03-31 under approval number K192413. 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 SiteSeal Femoral Compression Device?

SiteSeal Femoral Compression Device is a medical device that received FDA 510(k) clearance on 2020-03-31. It is manufactured by Ensite Vacular, LLC. The 510(k) number is K192413.

When was SiteSeal Femoral Compression Device approved by the FDA?

SiteSeal Femoral Compression Device received FDA 510(k) clearance on 2020-03-31, under approval number K192413.

What company makes SiteSeal Femoral Compression Device?

SiteSeal Femoral Compression Device is manufactured by Ensite Vacular, LLC.

What is the FDA product code for SiteSeal Femoral Compression Device?

The FDA product code for SiteSeal Femoral Compression Device is DXC.

Related Clinical Trials

NCT07613931 Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment 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 NCT07600489 A Randomized Non-Inferiority Study of Mepi™ Press 2 vs UrgoK2® for Compression Therapy in Venous Leg Ulcers NOT_YET_RECRUITING NCT07573189 The Effects of Recovery Compression Boots on Blood Lactate Levels, Functional Movement, and Joint Ange of Motion in Collegiate Athletes. ACTIVE_NOT_RECRUITING NCT06911385 Augmenting Cerebral Blood Flow in Acute Ischemic Stroke NOT_YET_RECRUITING

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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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