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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 the device name listed in this FDA 510(k) record. The listed applicant is Ensite Vacular, LLC. It received FDA 510(k) clearance on 2020-03-31 under 510(k) 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. The listed applicant is Ensite Vacular, LLC. The 510(k) number is K192413.

When did SiteSeal Femoral Compression Device receive FDA 510(k) clearance?

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

Who is the listed applicant for SiteSeal Femoral Compression Device?

The FDA 510(k) record lists Ensite Vacular, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: DXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262086PreludeSYNC™ Radial Compression DeviceMerit Medical Systems, Inc.K260105Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards LifesciencesK252772Arc Adjustable Radial Cuff Compression DeviceTz Medical, Inc.K254060Life Saving TourniquetTW MedicalK243627Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)Arc Trauma, LLCK253070Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)Medline Industries, LP

Official Source

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

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