Search Results
Found 2 results
510(k) Data Aggregation
K Number
K030443Device Name
MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST
Manufacturer
Date Cleared
2003-05-09
(87 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
NASTECH PHARMACEUTICAL COMPANY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MASCT device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
Device Description
The Nastech MASCT device is similar to the non-powered breast aspirators manufactured by Nastech Pharmaceutical Company, Inc. and Pro-Duct Health, Inc. used to elicit and collect nipple aspirate fluid (NAF) from the excretory ducts (tubuli lactiferi or galactophori). The device is comprised of a rigid polycarbonate cup in which the sample collection container is inserted. Negative pressure (vacuum) is produced by nonpowered (hand) actuations of a lever like handle. The expressed NAF sample is collected on a membrane filter and washed into the sample container using an appropriate fixative solution.
Ask a Question
Ask a specific question about this device
K Number
K012088Device Name
NASTECH MAMMARY ASPIRATION SPECIMAN CYTOLOGY TEST MASCT
Manufacturer
Date Cleared
2001-12-18
(168 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
NASTECH PHARMACEUTICAL COMPANY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MASCT device is intended for use in the collection of nipple aspirate fluid for laboratory cytological testing.
Device Description
The Nastech MASCT device is similar to the non-powered breast pumps Manufactured by Windy Hill Technology used to elicit and collect nipple aspirate fluid (NAF) from the excretory ducts (tubuli lactiferi or galactophori). The device is comprised of a rigid polycarbonate cup in which the sample collection container is inserted. Negative pressure (vacuum) is produced by non-powered (hand) actuations of a lever like handle. The expressed NAF sample is collected on a membrane filter and washed into the sample container using an appropriate fixative solution.
Ask a Question
Ask a specific question about this device
Page 1 of 1