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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

K112327 is an FDA 510(k) premarket notification submitted by Cardiac Assist, Maquet Cardiovascular, LLC for the device "SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on September 9, 2011. The device falls under product code DSP (System, Balloon, Intra-Aortic And Control), a Class II device regulated under 21 CFR 870.3535. Cardiac Assist, Maquet Cardiovascular, LLC has at least 1 other 510(k) clearance on record.

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

  • K112372 — CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (September 15, 2011)

Other clearances for product code DSP

  • K250542 — AC3™ Range™ Intra-Aortic Balloon Pump (March 26, 2025)
  • K232343 — AC3™ Series IABP (August 30, 2023)
  • K201112 — AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP (May 27, 2020)
  • K200634 — Arrow FiberOptix Intra-Aortic Balloon Catheter Kit (April 9, 2020)
  • K192238 — AC3 Series Intra-Aortic Balloon Pump (IABP) (November 12, 2019)
  • K190101 — UltraFlex IAB (June 28, 2019)
  • K190117 — Fiberoptix IAB (June 13, 2019)
  • K181122 — CARDIOSAVE Intra-Aortic Balloon Pump (May 31, 2018)
  • K172305 — CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump (October 12, 2017)
  • K162820 — AC3 Series IABP System (March 31, 2017)

FDA data resources