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510(k) K041281

DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES by Datascope Corp. — Product Code DSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 2004
Date Received
May 13, 2004
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

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  • K063525 — DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 IN (January 5, 2007)

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