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FDA 510(k)

Site Seal SV

K-Number: K190351 · 2019-07-02

ApplicantEnsite Vascular
Decision Date2019-07-02
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Site Seal SV is the device name listed in this FDA 510(k) record. The listed applicant is Ensite Vascular. It received FDA 510(k) clearance on 2019-07-02 under 510(k) number K190351. 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 Site Seal SV?

Site Seal SV is a medical device that received FDA 510(k) clearance on 2019-07-02. The listed applicant is Ensite Vascular. The 510(k) number is K190351.

When did Site Seal SV receive FDA 510(k) clearance?

Site Seal SV received FDA 510(k) clearance on 2019-07-02, under 510(k) number K190351.

Who is the listed applicant for Site Seal SV?

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

What is the FDA product code for Site Seal SV?

The FDA product code for Site Seal SV is DXC.

Other records listing Ensite Vascular as applicant

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.

K210681SiteSeal SV

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

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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