FDA.reportPublic FDA data

510(k) K000729

Device
ARROW ULTRA 8 INTRA-AORTIC BALLOON CATHETERS (IABS) 8FR 30CC AND 40CC UNIVERSAL
Applicant
ARROW INTL., INC.
510(k) number
K000729
Product code
DSP  
Decision
Substantially Equivalent (SESE)
Decision date
2000-05-19
Date received
2000-03-06
Regulation
870.3535
Classification name
System, Balloon, Intra-aortic And Control
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM PAQUIN
Address
9 Plymouth St. Everett MA US 02149 02149

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DSP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250542AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLC2025-03-26
K232343AC3™ Series IABPArrow International, LLC2023-08-30
K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.2020-05-27
K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc.2020-04-09
K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, Teleflex2019-11-12
K190101UltraFlex IABArrow International, Inc.2019-06-28
K190117Fiberoptix IABArrow International, Inc.2019-06-13
K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp.2018-05-31
K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp.2017-10-12
K162820AC3 Series IABP SystemArrow International, Inc.2017-03-31
K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseDatascope Corp.2017-01-31
K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp.2015-07-02
K133074MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIESDatascope Corp.2013-12-12
K122628SENSATION PLUS 7.5FR. 40CC INTRA-AORTIC BALLOON (IAB) CATHETER AND ACCESSORIESDatascope Corp., Cardiac Assist Division2012-09-06
K120868MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETERDatascope Corp., Cardiac Assist Division2012-04-20

Legacy Summary#

summary