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510(k) Data Aggregation
K Number
K122152Device Name
OXTI INFLATION DEVICE
Manufacturer
Date Cleared
2012-12-14
(147 days)
Product Code
Regulation Number
870.1650Why did this record match?
Applicant Name (Manufacturer) :
OXTI CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OXTI Inflation Device is indicated for use during cardiovascular procedures to create, maintain, and monitor pressure in a balloon dilation catheter.
Device Description
The device consists of three major components; a) 30ml barrel, b) inflation mechanism and c) 6% standard conical fitting and stopcocks system for connecting to the PTCA catheter. The barrel has graduation markings at 0.5ml interval to the full 30ml capacity A dual scale pressure gauge mounted at distal end of the barrel is capable of indicating pressure up to 30atm at 1atm or 10psi intervals. Reinforced polyurethane tubing extending from the svringe exit port connects to a 6% male/female conical fitting for attaching to the 3-way stopcock and to the angiographic catheter.
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