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510(k) Data Aggregation
K Number
K093565Device Name
PLEURAFLOW CATHETER SYSTEM
Manufacturer
Date Cleared
2010-12-03
(380 days)
Product Code
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
CLEAR CATHETER SYSTEMS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PleuraFlow Catheter is indicated for use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound. The device is indicated for use in thoracic surgical procedures.
Device Description
The PleuraFlow Catheter System is comprised of a silicone drainage tube and a shuttle assembly and guide tube. The PleuraFlow drainage tube is 20 inches in length with graduated measurements in inches from the first side hole and will be available in standard sizes from 20Fr to 32Fr versions. There is a barium stripe in the tube to facilitate visualization. A connector at the proximal end of the device connects to a commercially available drainage system. Within the catheter is a tube clearance apparatus to facilitate clearing of the drainage tube. The tube clearance apparatus is composed of a PTFE-coated guide wire that has a loop set on its distal end, bent at a 90-degree angle. The clearance apparatus is sized such that it cannot exit the end of the drainage tube or the side holes. The tube clearance apparatus is magnetically driven by an attached internal magnet coupled to an external magnet contained within the shuttle assembly.
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