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510(k) Data Aggregation
K Number
K182159Device Name
Strome-Blitzer Cytology Balloon
Manufacturer
ADN International LLC
Date Cleared
2019-06-13
(308 days)
Product Code
EOX, BTR, FDX
Regulation Number
874.4710Why did this record match?
Applicant Name (Manufacturer) :
ADN International LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Strome-Blitzer Cytology Balloon device is indicated for use in the 4-quadrant collection and retrieval of surface cells from the esophagus in adults (22 years of age or older). The device may be delivered transorally under direct endoscopic visualization.
Device Description
The Strome-Blitzer Cytology Balloon is an inflatable biopsy platform. It consists of a catheter with a silicone balloon at its distal end. The balloon has 6 collection pleats on its surface. Inside each pleat are 2 cytology collection strips for specimen collection. While the balloon is uninflated, the strips are covered by the balloon pleats. When inflated, the strips are exposed. The balloon inflates and deflates with the use of a syringe and attached catheter, and is a sterile, single-use device. There are 4 location indicator dots on the proximal balloon surface for orientation during esophagoscopy.
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