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510(k) Data Aggregation
K Number
K041504Device Name
HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01
Manufacturer
Date Cleared
2004-08-06
(60 days)
Product Code
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
HAEMACURE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The HemaMyst Surgical Applicator System is indicated for the simultaneous application of the two separate components of HEMASEEL APR Fibrin Sealant or Tisseel VH Fibrin Sealant to the treatment site.
Device Description
The HemaMyst Surgical Applicator System is a sterile, single-use device consisting of a Head that attaches by Luer connectors to currently available dual syringe spray noals and is coupled to an air regulator base unit by means of a sterile filtered air applicators, and is obablicator System allows simultaneous delivery, by spraying, of the two components of fibrin sealant to the treatment site.
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K Number
K994023Device Name
HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01
Manufacturer
Date Cleared
2000-04-25
(151 days)
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
HAEMACURE CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Haemacure HemaMyst Surgical Applicator System is indicated for the application of two non-homogeneous fluids or solutions to the treatment site.
Device Description
The Haemacure HemaMyst Surgical Applicator System consists of an air regulator that can be coupled with compressed gasses present in the operating suite, a foot pedal to control air flow; and a spray head that can be coupled to currently available dual syringe applicators with a filtered air line to connect the base unit to the applicator spray head.
The base unit with the regulator and foot pedal is provided non-sterile and sold as a reusable device.
The spray head and filtered gas tubing is ethylene oxide (EtO) sterilized and sold as a sterile, single-use device.
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