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510(k) Data Aggregation
K Number
K161659Device Name
FlexSeal Introducer Sheath with Hydrophilic Coating
Manufacturer
Date Cleared
2016-07-15
(29 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
LIBRA MEDICAL 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 Sheath with Hydrophilic Coating contains the following disposable components:
- o One sterile introducer sheath with an active spring loaded hemostatic valve
- o One sterile radiopaque dilator
The FlexSeal™ Introducer Sheath with Hydrophilic Coating consists of an introducer sheath with hydrophilic coating and a dilator. The devices sizes are 14F, 16F and 18F. Three different lengths (20 cm, 28 cm and 35 cm) are available for each FlexSeal introducer size. An active hemostatic valve is integrated into the sheath.
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