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510(k) Data Aggregation
K Number
K993342Device Name
DUCPREP BREAST ASPIRATOR, MODEL PMPO2
Manufacturer
Date Cleared
1999-12-23
(79 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
WINDY HILL TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DucPrep Breast Aspirator device is used to elicit fluid from multiple ductal orifices for subsequent cytological evaluation and/or to identify ductal orifices for subsequent cannulation with the WHT Fuji Catheter.
Device Description
The Windy Hill Technology DucPrep breast aspirator device is similar to nonpowered breast pumps used to express mill in lactating women. The device is comprised of a rigid polycarbonate cup which is connected to a small piece of polymer tubing. A flexible, silicone insert is placed inside of the rigid polycarbonate cup prior to device placement around the breast nipple. The tubing is attached to a standard syringe which is used to pull a gentle vacuum to express breast ductal fluid. The device is packaged in a Tyvek® pouch.
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K Number
K983867Device Name
FUJI CATHETER, MODEL CTH001
Manufacturer
Date Cleared
1999-06-09
(219 days)
Product Code
Regulation Number
876.1075Why did this record match?
Applicant Name (Manufacturer) :
WINDY HILL TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Fuji Catheter is designed to perform contrast enhanced radiography of breast milk ducts. It may also be used for the collection of cells and/or fluid for cytological analysis.
Device Description
The Windy Hill Technology Fuii Catheter is a dual lumen device with a flexible shaft. The hub located at the proximal end of the Fuii Catheter has two branches which each correspond with a single port. The entry port is used for saline or contrast infusion and is marked with an arrow pointing in the distal direction of the catheter. The corresponding entry lumen is located at the distal end of the catheter, adjacent to the 1 cm marker. The exit port is used for fluid collection and for quidewire introduction and is marked with an arrow pointing in the proximal direction of the catheter. The corresponding exit lumen is located at the distal tip of the catheter. The device is provided sterile and is intended for single use only.
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