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Found 6 results
510(k) Data Aggregation
K Number
K152183Device Name
EXELINT SecureTouch Safety Hypodermic Needle
Manufacturer
EXELINT INTERNATIONAL CO.
Date Cleared
2015-11-02
(89 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
EXELINT INTERNATIONAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EXELINT SecureTouch Safety Hypodermic Needle is intended for use with syringes for general purpose aspiration and medication administration. It has an antistick mechanism to cover the needle after use.
Device Description
EXELINT SecureTouch Safety Hypodermic Needle is a sterile, single use, standard luer lock compatible hypodermic needle with a protection shield to enclose the needle after use The device is available in 18 to 30 gauge in length from 10mm to 50mm. The purpose of this submission is to enable Exelint International, Co. to market a line of safety hypodermic needle.
The proposed device is available in EO sterilized sealed in a sterility maintenance package.
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K Number
K101309Device Name
EXELINT ALUMINUM HUB BLUNT NEEDLES
Manufacturer
EXELINT INTERNATIONAL CO.
Date Cleared
2010-10-20
(163 days)
Product Code
LHI, FMI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
EXELINT INTERNATIONAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EXELINT Aluminum Hub Blunt Needles are intended to be used in a variety of medical, pharmaceutical and laboratory procedures to extract fluid or medication from vials or ampoule for transfer or for irrigation.
Device Description
The EXELINT Aluminum Hub Blunt Needles are sterile, non-pyrogenic, single use fluid transfer needles consisting of blunt Type 304 stainless steel cannulas staked into aluminum luer lock hubs. The gauge and length of the cannula determines the final gauge and length of the product. The hubs are identical for all of the needles. Each needle is packaged into a Polypropylene tube and sealed with a polypropylene cap. The needles are final packaged into a multineedle box and ETO sterilized.
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K Number
K020189Device Name
EXEL BUTTERFLY SCALP VEIN SET
Manufacturer
EXELINT INTERNATIONAL CO.
Date Cleared
2003-03-27
(433 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
EXELINT INTERNATIONAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EXEL Scalp Vein (butterfly) set is used for administration of IV solution or infusion of medication to the patient via vascular system.
Device Description
Not Found
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K Number
K010197Device Name
EXEL SECURE TOUCH SAFETY (P.S.V.) SCALP VEIN SET
Manufacturer
EXELINT INTERNATIONAL CO.
Date Cleared
2001-05-14
(112 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
EXELINT INTERNATIONAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003627Device Name
EXEL SECURE TOUCH SAFETY A.V. FISTULA NEEDLE SET
Manufacturer
EXELINT INTERNATIONAL CO.
Date Cleared
2001-02-08
(76 days)
Product Code
FMI
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
EXELINT INTERNATIONAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K001496Device Name
A.V. FISTULA NEEDLE
Manufacturer
EXELINT INTERNATIONAL CO.
Date Cleared
2000-08-01
(78 days)
Product Code
FIE
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
EXELINT INTERNATIONAL CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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