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510(k) Data Aggregation
K Number
K023914Device Name
COAXIA FLOCONTROL CATHETER
Manufacturer
COAXIA INC
Date Cleared
2003-02-21
(88 days)
Product Code
MJN
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
COAXIA INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CoAxia FloControl™ Catheter is intended for use in selectively stopping or controlling blood flow in the peripheral vasculature.
Device Description
The CoAxia FloControl™ Catheter is a 9F multi-lumen device with two balloons mounted near the distal tip. The catheter is inserted over a .035" guide wire through a 9F introducer sheath. The device has a working length of 62 cm and is coated with a hydrophilic, heparin coating. A multi-port manifold at the proximal end of the device allows balloon inflation, guide wire insertion and attachment of a pressure monitoring line. Each balloon is 2 cm (20 mm) in length, separated by a distance of 8cm. Each balloon can be inflated independently to a diameter from 10mm to 20mm to control blood flow in the selected vessel. The device has 3 marker bands to aid in balloon placement. The catheter is EtO sterilized and is intended for single use only.
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