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510(k) K093510

LUMENVU CATHETER GUIDANCE SYSTEM by Sonosite,Inc. — Product Code OMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2010
Date Received
November 12, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

When used in connection with a locator instrument is designed to aid in the placement of central venous catheters by providing real-time information as to the position of the catheter inside the body during the catheter insertion procedure.

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Other clearances for product code OMF

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