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510(k) Data Aggregation
K Number
K111924Device Name
FINESSE PERSONAL INSULIN DELIVERY PATCH
Manufacturer
CALIBRA MEDICAL, INC.
Date Cleared
2012-04-10
(279 days)
Product Code
OPP, LZG
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
CALIBRA MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Finesse Insulin Delivery System is indicated for the subcutaneous, bolus delivery of physician prescribed insulins, in adult persons requiring such medications for the management of diabetes mellitus.
The Finesse Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
Device Description
The Finesse Insulin Delivery System (IDS) is comprised of a sterile. nonpyrogenic, single-use, external, disposable, ambulatory, liquid medication, bolus dosing device (IDD); a single use, non-pyrogenic, sterile. syringe and needle (Fill Syringe); a reusable Inserter; and a Dose Count Card. The device is intended for subcutaneous delivery of clinicianprescribed medications, and is adhered to the skin for up to 72 hours with a biocompatible adhesive.
The Insulin Delivery Device (IDD) is a manual, user filled, positive displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissues. The syringe and needle are for patient filling of the IDD with liquid medication prior to deployment on the body, and have a maximum capacity of 2ml. The Dose Count Card is utilized by the patient during the dosing session and provides for a written record of date, time and amount of Insulin delivery.
The Finesse IDS materials are biocompatible plastics, elastomers, and stainless steel.
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K Number
K100947Device Name
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
Manufacturer
CALIBRA MEDICAL, INC.
Date Cleared
2010-06-28
(83 days)
Product Code
OPP
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
CALIBRA MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Finesse Insulin Delivery System is intended for the subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in persons requiring insulin.
Device Description
The Finesse Insulin Delivery System is a sterile, nonpyrogenic, single-use, external, disposable, ambulatory, insulin, bolus dosing system through which clinician-prescribed medications are delivered subcutaneously. The Finesse Insulin Delivery System is composed of a positive volume displacement drug delivery device with infusion cannula and integrated Inserter, and a drug delivery device filler. The device is adhered to the skin with a biocompatible adhesive.
The Finesse Insulin Delivery System has an integrated cannula and Inserter. The infusion cannula Inserter is used to place the cannula in the subcutaneous tissues. It contains an insertion needle located in the lumen of the infusion catheter cannula. A safety mechanism prevents premature actuation of the insertion needle mechanism to prevent injuries. Following cannula placement, the needle is retracted within the body of the Inserter to prevent sharps exposure. Once the needle is retracted, the Inserter automatically releases the Inserter from the drug delivery component.
The Finesse Insulin Delivery System materials are biocompatible plastics, elastomers, and stainless steel.
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K Number
K093065Device Name
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000
Manufacturer
CALIBRA MEDICAL, INC.
Date Cleared
2010-01-20
(112 days)
Product Code
OPP, LZG
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
CALIBRA MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Finesse Insulin Delivery System is intended for the subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in persons requiring insulin.
Device Description
The Finesse Insulin Delivery System is a sterile, nonpyrogenic, single-use, external, disposable, ambulatory, insulin, bolus dosing system through which clinician-prescribed medications are delivered subcutaneously. The Finesse Insulin Delivery System is composed of a positive volume displacement drug delivery device with infusion cannula and integrated Inserter, and drug delivery device filler. The device is adhered to the skin for up to 48 hours with a biocompatible adhesive. The Finesse Insulin Delivery System has an integrated cannula and Inserter. The infusion cannula Inserter is used to place the cannula in the subcutaneous tissues. It contains an insertion needle located in the lumen of the infusion catheter cannula. A safety mechanism prevents premature actuation of the insertion needle mechanism to prevent injuries. Following cannula placement, the needle is retracted within the body of the Inserter to prevent sharps exposure. Once the needle is retracted, the Inserter automatically releases the Inserter from the drug delivery component. The Finesse Insulin Delivery System materials are biocompatible plastics, elastomers, and stainless steel.
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