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Found 3 results
510(k) Data Aggregation
K Number
K994323Device Name
KAWASUMI LABORATORIES PHILEBOTOMY SET
Manufacturer
KAWASUMI LABORATORIES CO., LTD.
Date Cleared
2000-03-08
(77 days)
Product Code
LHI
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
KAWASUMI LABORATORIES CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
A CONDUIT FOR BLOOD REMOVAL FROM A PATIENT TO A VACUUM BOTTLE TO AID IN THE TREATMENT OF A DISEASE OR OTHER CONDITION.
Device Description
A STERILE, SINGLE USE DEVICE FOR WITHDRAWING BLOOD. BASIC CONCEPT: A CONDUIT USED FOR WITHDRAWING BLOOD FROM THE PATIENT'S VEIN TO A VACUUM BOTTLE RESERVOIR
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K Number
K974829Device Name
NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET)
Manufacturer
KAWASUMI LABORATORIES CO., LTD.
Date Cleared
1998-02-12
(50 days)
Product Code
LJT
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
KAWASUMI LABORATORIES CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INFUSION OF FLUIDS, INCLUDING THOSE CONTAINING MEDICATIONS, FROM A CONTAINER TO A PORT IMPLANTED IN, OR OTHERWISE ATTACHED TO, A PATIENT TO AID IN THE DIAGNOSIS OR TREATMENT OF DISEASE OR OTHER CONDITIONS.
Device Description
A NON-PVC PORT ACCESS INFUSION SET IS A STERILE, SINGLE USE DEVICE WITH A NEEDLE, WING, NON-PVC I.D. TUBING AND NON-PVC COMPONENTS USED FOR ACCESSING IMPLANTED MEDICATION PORTS.
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K Number
K964117Device Name
NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE
Manufacturer
KAWASUMI LABORATORIES CO., LTD.
Date Cleared
1997-03-14
(150 days)
Product Code
LJT
Regulation Number
880.5965Why did this record match?
Applicant Name (Manufacturer) :
KAWASUMI LABORATORIES CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ROUTINELY USED TO ACCESS IMPLANTED MEDICATION PORTS FOR THE DELIVERY OF MEDICATIONS.
Device Description
A NON-PVC PORT ACCESS INFUSION SET IS A STERILE, SINGLE USE DEVICE WITH A NEEDLE, WING, NON-PVC I.D. TUBING AND NON-PVC COMPONENTS USED FOR ACCESSING IMPLANTED MEDICATION PORTS.
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