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510(k) K112327

SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES by Cardiac Assist, Maquet Cardiovascular, LLC — Product Code DSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 2011
Date Received
August 12, 2011
Clearance Type
Special
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

Other clearances by Cardiac Assist, Maquet Cardiovascular, LLC

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