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510(k) Data Aggregation
K Number
K043527Device Name
RELIEVA SINUS BALLOON DILATION CATHETER
Manufacturer
EXPLORAMED NC1, INC.
Date Cleared
2005-04-05
(105 days)
Product Code
LRC
Regulation Number
874.4420Why did this record match?
Applicant Name (Manufacturer) :
EXPLORAMED NC1, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Relieva Sinus Balloon Dilation Catheter is intended to provide a means to dilate ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.
Device Description
The Relieva Sinus Balloon Dilation Catheter will be provided in the following balloon sizes:
- 3 mm Sinus Balloon Catheter .
- 5 mm Sinus Balloon Catheter .
- 7 mm Sinus Balloon Catheter .
The family of Relieva Sinus Balloon Dilation Catheters allows for the enlargement of sinus ostia and paranasal spaces with a minimally invasive method. The Relieva Sinus Balloon Dilation Catheters are placed in the narrow opening over a guidewire. Once positioned the balloons are inflated with a high pressure inflation device that provides feedback as to the internal pressure of the balloon. After a few seconds at the desired balloon inflation pressure, the balloon can be deflated and removed or repositioned.
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