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Found 4 results
510(k) Data Aggregation
K Number
K123325Device Name
Medafor Direct Gas-Assisted Application System
Manufacturer
MEDAFOR, INC.
Date Cleared
2013-01-24
(90 days)
Product Code
GCJ
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
MEDAFOR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended to assist the delivery of a powdered hemostatic agent to the treatment site in surgical procedures including endoscopic surgeries, using a 5 mm or larger trocar.
Device Description
The MEDAFOR DIRECT Gas-Assisted Application System is intended to be used on patients undergoing surgery including laparoscopic procedures. The gas-assisted applicator kit and regulator are provided to assist the user in the application of powdered hemostatic agents to bleeding tissue in surgical procedures including laparoscopic/endoscopic surgeries, using a 5 mm or larger trocar. The device system consists of a Gas Regulator, Foot pedal, Tubing set, Adapter Handle, and FlexiTip XL-R rigid applicator. The gas regulator and foot pedal are supplied separately as non-sterile, reusable components. The Gas-Assisted Applicator kit is provided as a sterile, disposable unit, consisting of the tubing set, applicator adapter and a single unit of FlexiTip XL-R applicator.
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K Number
K033666Device Name
HEMADERM
Manufacturer
MEDAFOR, INC.
Date Cleared
2003-12-17
(26 days)
Product Code
QSY, LYA, NHB
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MEDAFOR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HemaDerm™ is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological,) minor cuts, and lacerations and for the temporary treatment of mild bleeding from topical ENT surgical wounds and nosebleeds.
HemaDerm™ is intended for use under the care of a health care professional for the local management and control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.
Device Description
HemaDerm™ containing MPH (Microporous Polysaccharide Hemospheres™ ) is manufactured from purified plant based polysaccharide. The porosity is controlled such that the particles act as molecular sieves excluding large proteins and cells. The bleeding cessation is accomplished by the rapid dehydration and subsequent hemoconcentration of blood in contact with the particles. The concentration of serum proteins and cells produces a viscous gel. Normal platelet activation and fibrin deposition within the congealed blood produces a clot that limits further bleeding.
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K Number
K021678Device Name
HEMADERM COTAINING HEMADEX CLOTTING BEADS
Manufacturer
MEDAFOR, INC.
Date Cleared
2002-07-12
(52 days)
Product Code
QSY, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MEDAFOR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HemaDerm™ is intended for use under the care of a health care professional as a topical dressing for the temporary treatment of severely bleeding wounds such as surgical wounds (post-operative, donor sites, dermatological), minor cuts and lacerations.
HemaDerm™ is intended for use under the care of a health care professional for the local management and control of bleeding from percutaneous needle access, vascular access sites and percutaneous catheters.
Device Description
Medafor. Inc.'s HemaDerm™ consists of dry, sterile, controlled porosity, spherical particles manufactured from purified plant based polysaccharide. The porosity is controlled such that the particles act as molecular sieves excluding large proteins and cells.
The bleeding cessation is accomplished by the rapid dehydration and subsequent hemoconcentration of blood in contact with the particles. The concentration of serum proteins and cells produces a viscous gel. Normal platelet activation and fibrin deposition within the congealed blood produces a clot that limits further bleeding.
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K Number
K013225Device Name
INSTACLOT FOR OTC USE, TRAUMASSTAT FOR PRESCRIPTION USE
Manufacturer
MEDAFOR, INC.
Date Cleared
2001-12-26
(90 days)
Product Code
KMF
Regulation Number
880.5090Why did this record match?
Applicant Name (Manufacturer) :
MEDAFOR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Over the Counter, OTC:
Bleed-X™ is intended as a topical dressing for the local management of bleeding wounds such as minor cuts, lacerations and abrasions.
Prescription, Rx:
Traumadex™ is intended as a topical dressing for the local management of bleeding wounds such as cuts, lacerations and abrasions. Under the care of a health care professional, Traumadex™ may be used for the temporary treatment of severely bleeding wounds such us surgical wounds (post-operative, donor sites, dermatological), cuts, lacerations and traumatic injuries.
Device Description
Medafor, Inc.'s Bleed-X™ and Traumadex™ consists of dry, sterile, controlled porosity, spherical particles manufactured from purified plant based polysaccharide. The porosity is controlled such that the particles act as molecular sieves excluding large proteins and cells.
The bleeding cessation is accomplished by the rapid dehydration and subsequent hemoconcentration of blood in contact with the particles. The concentration of serum proteins and cells produces a viscous gel. Normal plateler activation and fibrin deposition within the congealed blood produces a clot that limits further bleeding.
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