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510(k) Data Aggregation
K Number
K091690Device Name
SHARP CHUTE
Manufacturer
Date Cleared
2009-07-28
(48 days)
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
HEATHROW SCIENTIFIC, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sharp Chute TM is an over-the-counter, single-use, disposable, non-sterile sharps container intended to be used with medical sharps including, but not limited to, hypodermic needles, syringes, lancets, and blood needles. The containers can be used in any area requiring sharps collection prior to their final disposal.
When the container is filled to the max-capacity indicator, it is intended to be permanently locked and ultimately disposed of.
Device Description
The Sharp Chute ™ is a portable, 1.5 quart sharps container designed to be used in . environments where larger containers are not desired. In addition, it is designed to fit into Heathrow Scientific's Droplet™ Blood Collection Tray.
The Sharp Chute ™ is available in either translucent red or translucent yellow.
Each component of the container assembly is made of injection molded polypropylene.
The end user will be required to attach the dome assembly to the base by inserting the . connection tabs into their corresponding slots.
The Sharp Chute "1 is designed to withstand punctures by syringes, pen needles, and . lancets.
The Sharp Chute "M is autoclavable and incineratable. .
The Sharp Chute TM is NOT reusable. .
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