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510(k) Data Aggregation
K Number
K091194Device Name
ALGISEAL PAD
Manufacturer
Date Cleared
2009-05-18
(25 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
EVOLUTION MEDICAL TECHNOLOGIES LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Algiseal Pad (calcium alginate pad alone and pad with permeable adhesive backing): Algiseal Pad is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incision. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis patients and in patients on anticoagulation therapy. May be used in conjunction with a facility approved, posthemostasis site dressing.
Device Description
Algiseal Pad - (Varying size, with and without permeable adhesive backing, packaged sterile) Pads may be used alone as a wound dressing. The Pad may also be used with manual pressure or FDA cleared mechanical pressure devices to provide rapid control of bleeding and hemostasis at the skin surface. May be used in conjunction with a facility approved, post-hemostasis site dressing.
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