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510(k) K122628

SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES by Datascope Corp., Cardiac Assist Division — Product Code DSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 2012
Date Received
August 28, 2012
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 Datascope Corp., Cardiac Assist Division

  • K122405 — AIR-BAND RADIAL COMPRESSION DEVICE (November 9, 2012)
  • K120868 — MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5 (April 20, 2012)
  • K091449 — DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684 (June 18, 2009)

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