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DSP — System, Balloon, Intra-Aortic And Control Class II

FDA Device Classification

Classification Details

Product Code
DSP
Device Class
Class II
Regulation Number
870.3535
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250542arrow internationalAC3™ Range™ Intra-Aortic Balloon PumpMarch 26, 2025
K232343arrow internationalAC3™ Series IABPAugust 30, 2023
K201112arrow internationalAC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPMay 27, 2020
K200634arrow internationalArrow FiberOptix Intra-Aortic Balloon Catheter KitApril 9, 2020
K192238arrow international, teleflexAC3 Series Intra-Aortic Balloon Pump (IABP)November 12, 2019
K190101arrow internationalUltraFlex IABJune 28, 2019
K190117arrow internationalFiberoptix IABJune 13, 2019
K181122datascopeCARDIOSAVE Intra-Aortic Balloon PumpMay 31, 2018
K172305datascopeCS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpOctober 12, 2017
K162820arrow internationalAC3 Series IABP SystemMarch 31, 2017
K163542datascopeCARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion BatterJanuary 31, 2017
K151254datascopeCARDIOSAVE Hybrid Intra-Aortic Balloon PumpJuly 2, 2015
K133074datascopeMEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ADecember 12, 2013
K122628datascope corp., cardiac assist divisionSENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIESSeptember 6, 2012
K120868datascope corp., cardiac assist divisionMEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5April 20, 2012
K112372cardiac assist, maquet cardiovascularCARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMPSeptember 15, 2011
K112327cardiac assist, maquet cardiovascularSENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIESSeptember 9, 2011
K091449datascope corp., cardiac assist divisionDATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684June 18, 2009
K082746insightra medicalULTRA IABP CATHETER KIT, MODELS IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, IMU7F-20January 12, 2009
K070225abiomedSUPRACOR INTR-AORTIC BALLOON PUMP CONSOLEDecember 13, 2007