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510(k) K070225

SUPRACOR INTR-AORTIC BALLOON PUMP CONSOLE by Abiomed, Inc. — Product Code DSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 13, 2007
Date Received
January 24, 2007
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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