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510(k) K945963

THE OMNIGUIDE GUIDING CATHETER WITH BALLOON by Micro Interventional Systems, Inc. — Product Code DQT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1995
Date Received
December 7, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Occluder, Catheter Tip
Device Class
Class II
Regulation Number
870.1370
Review Panel
CV
Submission Type

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