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510(k) Data Aggregation
K Number
K142548Device Name
MIDSLEEVE
Manufacturer
Date Cleared
2015-06-23
(286 days)
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL INNOVATION DEVELOPMENT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
MIDSLEEVE, Calibration Tube for Sleeve Gastrectomy is indicated for use in the bariatric procedure known as Longitudinal Sleeve Gastrectomy (LSG), to drain and remove gastric fluid and to provide a calibration of the gastric pouch.
Device Description
MIDSLEEVE™ Calibration tube for Sleeve Gastrectomy is a sterile, single use medical device which consists of a 900 mm long, silicone tube of 37.5 French diameter, with a PVC valve at the proximal end of the tube. The tube has several holes and a rounded end, distal from the valve and an asymmetric balloon which can be filled through the valve. Reference markings are provided on the tube, from the distal end to 70 cm to locate the tube position.
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