Product Code: DSP


Products Classified as DSP

772System, Balloon, Intra-aortic And ControlIntra-aortic Balloon And Control System.

Total Product Life Cycle (TPLC) Devices

772System, Balloon, Intra-aortic And ControlIntra-aortic Balloon And Control System.

Pre-market Notifications for DSP

K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International Inc.
K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International Inc.
K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, Teleflex
K190117Fiberoptix IABArrow International, Inc.
K190101UltraFlex IABArrow International, Inc.
K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp.
K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp.
K163542CARDIOSAVE Hybrid And Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport And Storage CaseDatascope Corp.
K162820AC3 Series IABP SystemARROW INTERNATIONAL, INC.
K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDATASCOPE CORP.
K133074MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIESDATASCOPE CORP.
K122628SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIESDATASCOPE CORP., CARDIAC ASSIST DIVISION
K120868MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETERDATASCOPE CORP., CARDIAC ASSIST DIVISION
K112372CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMPCARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
K112327SENSATION(TM) PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIESCARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC

Global Unique Device Identification Database

00801902136749System, balloon, intra-aortic and control
00801902136732System, balloon, intra-aortic and control
00801902136725System, balloon, intra-aortic and control
00801902136718System, balloon, intra-aortic and control
00801902136701System, balloon, intra-aortic and control
00801902136695System, balloon, intra-aortic and control
00801902092885System, balloon, intra-aortic and control
00801902092878System, balloon, intra-aortic and control
00801902092854System, balloon, intra-aortic and control
30801902091155System, balloon, intra-aortic and control
00801902089441System, balloon, intra-aortic and control
00801902089434System, balloon, intra-aortic and control
00801902089380System, balloon, intra-aortic and control
00801902086778System, balloon, intra-aortic and control
30801902086762System, balloon, intra-aortic and control

Maude Adverse Events

CARDIOSAVE HYBRID TYPE B PLUGDATASCOPE CORP. - MAHWAH2020-03-31
CARDIOSAVE HYBRID TYPE B PLUGDDATASCOPE CORP. - MAHWAH2020-03-31
CS300DATASCOPE CORP. - MAHWAH2020-03-31
SENSATION PLUS 8FR. 50CCDATASCOPE CORP. - FAIRFIELD2020-03-31
SENSATION PLUS 8FR. 50CCDATASCOPE CORP. - FAIRFIELD2020-03-31
SENSATION PLUS 8FR. 50CCDATASCOPE CORP. - FAIRFIELD2020-03-31
CS300DATASCOPE CORP. - MAHWAH2020-03-31
CARDIOSAVE HYBRID TYPE B PLUGDATASCOPE CORP. - MAHWAH2020-03-31
TRANS-RAY PLUS 7.5 FR. 40CCDATASCOPE CORP. - FAIRFIELD2020-03-31
CS300DATASCOPE CORP. - MAHWAH2020-03-31
UNKNOWN IABDATASCOPE CORP. - FAIRFIELD2020-03-31
AUTOCAT 2ARROW INTERNATIONAL INC.2020-03-31
CARDIOSAVE HYBRID INT TYPE G PLUGDATASCOPE CORP. - MAHWAH2020-03-30
CARDIOSAVE HYBRID TYPE B PLUGDATASCOPE CORP. - MAHWAH2020-03-30
CS300DATASCOPE CORP. - MAHWAH2020-03-30
CS300DATASCOPE CORP. - MAHWAH2020-03-30
CARDIOSAVE HYBRID TYPE B PLUGDATASCOPE CORP. - MAHWAH2020-03-30
CS300DATASCOPE CORP. - MAHWAH2020-03-30
CARDIOSAVE HYBRID TYPE B PLUGDATASCOPE CORP. - MAHWAH2020-03-30
TRANS-RAY PLUS 7.5 FR. 40CCDATASCOPE CORP. - FAIRFIELD2020-03-30
TRANS-RAY 7FR. 34CCDATASCOPE CORP. - FAIRFIELD2020-03-30
TRANS-RAY 7FR. 40CCDATASCOPE CORP. - FAIRFIELD2020-03-30
SENSATION PLUS 8FR. 50CCDATASCOPE CORP. - FAIRFIELD2020-03-30
AC3 OPTIMUS IABP NA/EMEAARROW INTERNATIONAL INC.2020-03-30
FIBEROPTIX ULTRA 8 IAB: 8FR 40CCARROW INTERNATIONAL INC.2020-03-30
FIBEROPTIX ULTRA 8 IAB: 8FR 30CCARROW INTERNATIONAL INC.2020-03-30
FIBEROPTIX ULTRA 8 IAB: 8FR 40CCARROW INTERNATIONAL INC.2020-03-30
CS300DATASCOPE CORP. - MAHWAH2020-03-27
CARDIOSAVE HYBRID TYPE B PLUGDATASCOPE CORP. - MAHWAH2020-03-27
CS300DATASCOPE CORP. - MAHWAH2020-03-27
CS300DATASCOPE CORP. - MAHWAH2020-03-27
CARDIOSAVE HYBRID TYPE B PLUGDATASCOPE CORP. - MAHWAH2020-03-27
CS300DATASCOPE CORP. - MAHWAH2020-03-27
CS300DATASCOPE CORP. - MAHWAH2020-03-27
CARDIOSAVE HYBRID INT TYPE E/F PLUGDATASCOPE CORP. - MAHWAH2020-03-27
UNKNOWNDATASCOPE CORP. - MAHWAH2020-03-27
CARDIOSAVE HYBRID TYPE B PLUGDATASCOPE CORP. - MAHWAH2020-03-27
CARDIOSAVE HYBRID TYPE B PLUGDATASCOPE CORP. - MAHWAH2020-03-26
CS300DATASCOPE CORP. - MAHWAH2020-03-26
CS300DATASCOPE CORP. - MAHWAH2020-03-26
CARDIOSAVE HYBRID TYPE B PLUGDATASCOPE CORP. - MAHWAH2020-03-26
CARDIOSAVE HYBRID TYPE B PLUGDATASCOPE CORP. - MAHWAH2020-03-26
CS300DATASCOPE CORP. - MAHWAH2020-03-26
CARDIOSAVE HYBRID TYPE B PLUGDATASCOPE CORP. - MAHWAH2020-03-26
CS300DATASCOPE CORP. - MAHWAH2020-03-26
CARDIOSAVE HYBRID TYPE B PLUGDATASCOPE CORP. - MAHWAH2020-03-26
CS300DATASCOPE CORP. - MAHWAH2020-03-26
CS300DATASCOPE CORP. - MAHWAH2020-03-26
AC3 OPTIMUS IABP NA/EMEAARROW INTERNATIONAL INC.2020-03-26
CARDIOSAVE HYBRID TYPE B PLUGDATASCOPE CORP. - MAHWAH2020-03-26

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