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510(k) Data Aggregation
K Number
K101097Device Name
CALGAESEAL MODEL: CAS
Manufacturer
Date Cleared
2010-09-22
(155 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BZ MEDICAL INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CalgaeSeal is used to promote the rapid control of bleeding and provide hemostasis for lacerations, abrasions, vascular access sites and following surgical incisions. It can be used to achieve hemostasis at the skin surface for arterial/venous catheterization/tubes, needle puncture, hemodialysis and in patients on anticoagulation therapy. May be used in conjunction with a facility approved, post-hemostasis site dressing.
Device Description
CalgaeSeal is calcium alginate packaged in a Tyvek and Mylar pouch and sterilized by gamma radiation to a 10°-6 SAL and used as a topical hemostasis pad.
CalgaeSeal can be used alone as a wound dressing. It may be used in conjunction with manual pressure or FDA cleared mechanical pressure devices to provide rapid control of bleeding and hemostasis at the skin surface.
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