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510(k) K091449

DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 by Datascope Corp., Cardiac Assist Division — Product Code DSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2009
Date Received
May 18, 2009
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)
  • K122628 — SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIES (September 6, 2012)
  • K120868 — MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5 (April 20, 2012)

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