Search Results
Found 1 results
510(k) Data Aggregation
K Number
K090970Device Name
FLOCONTROL , MODEL 1028
Manufacturer
COAXIA, INC.
Date Cleared
2009-06-12
(67 days)
Product Code
MJN, CAT
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 which includes the descending aorta.
Device Description
The CoAxia FloControl™ Catheter is a 7F multi-lumen device with two balloons mounted near the distal tip. The catheter is inserted over a .035" guide wire through a 7F vascular introducer sheath. The device has a working length of 62 cm and is coated with a hydrophilic 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 8 cm. Each balloon can be inflated independently to a variable diameter to control blood flow in the selected vessel. When used in the descending aorta, balloon inflation results in diversion of cardiac output to the upper torso and core organs, e.g., cardiac, spinal and cerebral vasculature. The device has 3 marker bands to aid in balloon placement. The catheter is EtO sterilized and is intended for single use only.
Ask a Question
Page 1 of 1