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510(k) K082746

ULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20 by Insightra Medical, Inc. — Product Code DSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2009
Date Received
September 19, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Balloon, Intra-Aortic And Control
Device Class
Class II
Regulation Number
870.3535
Review Panel
CV
Submission Type

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