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510(k) Data Aggregation
K Number
K190628Device Name
FlexSeal Introducer Sheath with Hydrophilic Coating
Manufacturer
Date Cleared
2019-05-30
(79 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
Freudenberg Medical MIS, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FlexSeal® Introducer Sheath with Hydrophilic Coating is intended to be placed in the peripheral vasculature to provide a conduit for the introduction of diagnostic or interventional devices, and to minimize blood loss associated with such insertions.
Device Description
The FlexSeal Introducer set contains the following disposable components: One sterile introducer sheath with an active spring loaded hemostatic valve ● One sterile radiopaque dilator The FlexSeal Introducer set consists of an introducer sheath with hydrophilic coating and a dilator. The device size is 21Fr with a 56 cm shaft. An active hemostatic valve is integrated into the sheath. A Ring Lock at the proximal end of the device assists with the control of the hemostatic valve.
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